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Label Inspection

FDA 21 CFR PART 11

WHAT IS IT?FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper. The regulation applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical products, and covers: Required records that are maintained in electronic format in place of paper format Required records that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities Records submitted to FDA in electronic format Electronic signatures that are intended to be the equivalent of handwritten signatures In order to meet these regulations, companies turn to software to help bridge the gap. But a piece of software by itself cannot be compliant. Any critical software must be supported by a properly conceived and performed validation project, normally following GMP (as show below). ITS BENEFITSFDA 21 CFR Part 11 helps organizations reduce the cost of managing and documenting their entire labeling lifecycle, from routing and approval workflow, version control and comparison, to audit trails and reports. By becoming FDA 21 CFR Part 11 compliant, manufacturers will benefit from: Reduced costs by removing manual and paper processes whilst improving workflow processes Improved traceability - electronic records are simpler for gathering, filtering, and presenting information for internal use or FDA audits The ability to print, reprint and reconcile labels at any time Stronger controls over users’ ability to design, amend and approve labels Better management of global data including product data, symbols, graphics, and languages Download our Ensuring FDA Compliance Whitepaper Read our blog FDA Regulations for Inspection

UNIQUE DEVICE IDENTIFICATION – UDI

WHAT IS IT?The FDA’s Unique Device Identification (UDI) of medical devices aims to offer a practical solution to display standard product information in a standard format for a product’s distribution and use. This information needs to include a UDI in human and machine-readable form and includes (but is not limited to): the manufacturer of the device expiry dates the make and model of the device serial or lot number any special attributes that the device may possess. As part of the directive, organizations must submit the product information in a computer-readable structured labeling format to GUDID (Global Unique Device Identification Database) - a publicly searchable database.UDI is relevant to any organization working in or supplying medical device products (class I, II and III) to the USA. ITS BENEFITSUDI offers a range of benefits to industry, FDA, consumers, healthcare providers and healthcare systems by: Allowing more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly. Reducing medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device. Enhancing analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices. Providing a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls. Providing a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies. Leading to the development of a medical device identification system that is recognized around the world. Download our How The GUDID Was it? Webinar Read our blog: UDI: An inconvenience or a chance for change?

EUROPEAN MEDICAL DEVICE REGULATIONS – MDR

WHAT IS IT?The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. It is to have a fundamental revision in 2017 to better identify medical devices products and improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed). Similar to the FDA’s UDI, MDR will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation. EU MDR is relevant to any organization producing or supplying medical device products to Europe. To view the directive in draft format view EUMDR ITS BENEFITSUntil now, different European countries have interpreted and implemented the directive in different ways. By revising the directive EU MDR will enforce: Stricter pre-market control of high-risk devices at an EU level The inclusion of certain aesthetic products which present the same characteristics and risk profile as equivalent medical devices A new risk classification system for diagnostic medical devices based on international guidance Improved transparency through the establishment of a comprehensive EU database of medical devices (Eudamed) Device traceability through the supply chain from its manufacturer through to the final user An EU-wide requirement for an 'implant card' to be provided to patients containing information about implanted medical devices the reinforcement of the rules on clinical data and clinical studies on devices Manufacturers to collect data about the real-life use of their devices Improved coordination between EU Member States COMPLIANCE DATESThe new EU MDR directive is still in consultation phase, with the finalization of the directive working towards Q1 2017. The proposed rollout is 3 years from publication (2020) and 5 years for in-vitro diagnostic medical devices (2022). WHAT’S COMINGSo what exactly will change is still to be confirmed, however it is believed that the final directive will include the following: Wider scope for EU legislation on medical devices – extended to include items such as implants for aesthetic purposes New Eudamed database on medical devices that will provide comprehensive information on products available on the EU market Stronger European supervision of independent assessment bodies by national authorities Assessment bodies to have more powers to ensure thorough testing and regular checks on manufacturers Better traceability of medical devices throughout the supply chain –enabling a swift and effective response to safety problems Stricter requirements for clinical evidence to support assessments of medical devices Updated classification rules dividing IVDs into 4 different risk categories and health & safety requirements, including labelling rules International guidelines to be incorporated into EU law.   DOWNLOAD OUR MDR POSTER   Download the watch back of our MDR webinar: Bridging the Gap – How to be EU MDR Labeling Compliance Ready by Using the Lessons Learnt from UDI

Validation

Any pharmaceutical or medical device manufacturer who does not use validated software, relies on costly manual and paper processes which may compromise the safety, quality and value of its products. We support every element of validation - from initial installation to final performance testing. Our software can be supplied as a validated package, including auditable security protocols and lifecycle documentation, based on the GAMP V Model. Installation Qualification (IQ) – during deployment, our experienced Implementation Consultants are available to perform or oversee the installation and configuration of your system. This provides a more rapid deployment of systems while minimizing risk to your project delivery timeline. Operational/Performance Qualifications (OQ/PQ) –Our Implementation Consultants have successfully assisted many of our clients’ test and validate their solution against a wide range of technical and operational challenges and requirements, improving quality and efficiency in both the testing process itself and the delivery timeline.

Thank you

Thank you for registering for the Champions to Champions seminar. A reminder will be sent closer to the date. Please email us at \n This email address is being protected from spambots. You need JavaScript enabled to view it. if you would need hotel recommendations or if you have any questions. We are looking forward to meeting you at the event. Amanda ClementsChampions to Champions Event Coordinator

Champions to Champions

UPDATE: Unfortunately this event is postponed. Please accept our apologies for any inconveniences caused.   You are Invited to an Executive Event  Continental breakfast, complimentary lunch, refreshments and an exclusive tour of Gillette Stadium will be provided   There are many reasons that keep the medical device industry awake at night – however labeling as part of the supply chain can be a key concern. Businesses have to find ways to overcome the challenges of the label inspection, global implementation, language management or label postponement. 
 In order to minimize the risks and achieve zero-defect labeling and full traceability; to increase efficiency by optimizing your label production process or to improve compliance and avoid costly product recalls - you will need to implement your labeling system. Attend our information-packed seminar, featuring leading industry experts who will discuss best practices in implementing label lifecycle management solutions and will demonstrate how to seamlessly manage your labeling processes. Trends and challenges in the industry will also be discussed. Many businesses are not yet leveraging the true potential of their labeling solutions and so are not realizing the benefits of efficiency savings, productivity gains, watertight compliance and risk reduction.  Hear from Featured Leading Industry Experts: Bill Cooley - Industry Expert Chris Heckert - Network Packaging Partners Kevin Bogert - GxP Partners LLC Phil Dray - PRISYM ID More speakers to be confirmed. This is a full day event and a draft agenda will be available soon.  Key Benefits of attending are to: Gain an understanding of global lifecycle labeling in practical terms Learn from your peers who have successfully implemented label lifecycle management solutions within their business Understand the best practices for validation, managing source data, local language and just in time labeling   h1{ text-align:center; } div#content div#content-core ul, div#content div#content-core ol { list-style-image:none!important; }  

Validation; Business Gain Without the Pain White Paper

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Index Of Resources

Webinars Tips for Implementing FDA UDI without Derailing Production Achieving UDI Compliance – More Than Just a Label Change Automotive Component Labeling: How NSK Uses Technology to Accelerate Just-In-Time Deliveries Boston Scientific Share Advice on Streamlining End-to-end Label Lifecycle Management Mind Your Language; Controlling Labeling on a Global Scale Vision Inspection – Managing Label Defect Control Keeping Your Labeling System Ahead of the Curve A Best Practice Guide to Clinical Trials Labeling The GHS Countdown – Are You Prepared for the June 2015 deadline? Controlling Clinical Trials Labeling on a Global Scale Using integrated vision to achieve 100% FDA compliance Ensuring FDA Compliance: The Essential Guide to FDA 21CFR Part 11 Going Global: Best Practices for Managing Evolving Labeling Requirements A Revolution in Label Lifecycle Management - Taking a 360° View Dropping the Gavel on Counterfeit Drugs Label Production Under the Microscope PRISYM Design 6 Overview How The GUDID Was it? The Compliance Crackdown: Guarding Against FDA Action Mind the Gap! Labeling Experts share the 7 Steps of building a Global Labeling System and reducing the Validation effort Future-Proofing your Clinical Trial Supply Chain Bridging the Gap – How to be EU MDR Labeling Compliance Ready by Using the Lessons Learnt from UDI Filling the Gap - How Digital Transformation should be embraced when Building your Next-Generation Labeling System Label Compliance Challenges for Small and Medium Sized Medical Device Companies White Papers A Clear Vision: Developing the right strategy to assure compliant labeling inspection Delaying Tactics - How a Postponement Strategy can transform documentation processes and bring supply chain agility Mind Your Language! Requirements for Local Language Labeling in Clinical Trials Getting Ahead Of The Game: Implementing Unique Device Identification Without Derailing Production Label Production Under The Microscope: Can Vision Systems Safeguard Label Integrity? Ensuring FDA Compliance: The Essential Guide to FDA 21 CFR Part 11 Validation; Business Gain Without the Pain Time to Act - Has Judgment Day Arrived for Counterfeit Drugs? Aligning For Growth: The Evolution Of Medical Device Labeling How the GUDID was it for you?

Win an iPod nano

So, you want to know how you can be in with a chance of winning one of five iPod nanos? It's simple. 1. Register for the Marcus Evans event2. Stop by the PRISYM ID booth and say hi to one of our colleagues3. Complete our short survey4. Post your completed survey in the box provided5. Enjoy the rest of the conference! We'll pick five winners and make contact within three weeks - so please ensure you leave your correct contact details. Good Luck and see you at the event! Register \n This email address is being protected from spambots. You need JavaScript enabled to view it.    

Felfri etikettering för marknaden för medicinteknisk utrustning

Felfri etikettering för marknaden för medicinteknisk utrustning De olika problem som kan uppstå vid findetaljtryck har hindrat många tillverkare från att möta den höga industristandarden beträffande exakthet i användningen av etiketter vid paketering av medicinteknisk utrustning. Att personer eller delvis automatiserade system inspekterar dessa tryckproblem har visat sig vara otillräckligt, opålitligt och riskabelt. Automatisk 100 % simultaninspektionPrintInspector™ är ett trycksystem med simultanverifiering och hög noggrannhet. Det har utvecklats särskilt för den biotekniska marknaden, där etiketter ofta är långa och av komplext innehåll. Analys av dessa etiketter kräver en exakt registreringskontroll, lokaliserad belysning och en dedikerad bearbetnings- och avkodningsmotor för att säkerställa att varje etikett läses in, bearbetas och analyseras enligt högsta standard. Resultatet ger en sann Go/No-Go för etiketten samt en notis i granskningsloggen tillsammans med en fotograferad bild på varje misslyckad etikett. \n This email address is being protected from spambots. You need JavaScript enabled to view it. Titta på vår PrintInspector™-video för att se hur det fungerar PrintInspector™:s särdrag och fördelar 1. Reducerar den mänskliga faktorn genom att använda 100 % automatisk simultanidentifiering2. Dokumenterar inte bara det som skickats till skrivaren utan även vad som faktiskt tryckts och dokumenterar det i en unik granskningslogg3. Upptäckta problem markeras i en ”röd ruta” för snabb identifiering4. Erbjuder en minskning av hanteringskostnader och förebygger upptrappning av fel5. Använder simultaninspektion och nytryck i sekvens för felfri etikettering  

SYSTEM FÖR VISUELL INSPEKTION

SYSTEM FÖR VISUELL INSPEKTION Felfri etikettering för marknaden för medicinteknisk utrustning INSPEKTIONCrest Solutions PrintInspector™; ett trycksystem med simultanverifiering och hög noggrannhet kan levereras som extrautrustning till din bestående produktionsmärkningsprocess för att avlägsna behovet av manuell etikettinspektion. De olika problem som kan uppstå vid findetaljtryck har hindrat många tillverkare från att möta den höga industristandarden beträffande exakthet i användningen av etiketter vid paketering av medicinteknisk utrustning. Att personer eller delvis automatiserade system inspekterar dessa tryckproblem har visat sig vara otillräckligt, opålitligt och riskabelt. Användning av PrintInspector™ eliminerar dessa risker. PrintInspector™ är ett högutlösnings- (300dpi) avsökningssystem som monteras direkt på vanliga termo- eller laserskrivare för att åtgärda verifieringsproblem i samband med stora etikettformat på upp till A4 i storlek. TITTA PÅ VÅR PRINTINSPECTOR-VIDEO FÖR ATT SE HUR ETIKETTINSPEKTIONEN FUNGERAR PRISYM VISIONPRIZYM Vision erbjuder en förstklassig lösning genom en kombination av PRISYM Medica; en validerad märkningslösning utvecklad för ändamålet och Solutions PrintInspector™; ett tryckverifieringssystem med hög noggrannhet. Den integrerade etiketteringslösningen erbjuder tillverkare total etikettintegritet från design och tryck fram till etikettinspektion och eliminerar de risker som kan uppträda genom skrivarproblem, delvis automatiserade system och den mänskliga faktorn. De fel som identifieras automatiskt kommer nu inbegripa misstag som verkar små och som kan vara svåra att se med blotta ögat, såsom för lite eller för mycket trycksvärta, diagonala streck och strimmor, prickar och tomrum, svagt definierade tecken och offset eller tryck som har hamnat snett. Dessa misstag kan faktiskt leda till betydliga hälso- och säkerhetsproblem längre fram om de inte upptäcks. Lösningen dokumenterar inte bara det som skickats till skrivaren utan även vad som faktiskt tryckts och är dokumenterat i granskningsloggen, vilket innebär att fel kan upptäckas snabbt och åtgärdas effektivt. Detta är den första etikettdesign-lösning som når marknaden som tillåter tillverkare av medicinteknisk utrustning att designa etiketter, formatera dem färdiga för tryck och distribuera dem globalt till sina förpackningsställen. LADDA NED PRISYM VISIONS DATABLAD FÖR ATT VETA MER SÄRDRAG & FÖRDELARPRISYM Vision är den första lösningen för integrerad etikettdesign, versionskontroll, livscykelhanterings och visuell inspektion för tillverkare av medicinteknisk utrustning. Den möjliggör en användning av samma system för alla granskningselement. • Reducerar den mänskliga faktorn genom att automatiskt identifiera misstag som verkar små, som kan vara svåra att se med blotta ögat, såsom för lite eller för mycket trycksvärta, diagonala streck och strimmor, prickar och tomrum, svagt definierade tecken och offset eller tryck som har hamnat snett. Dessa misstag kan leda till betydliga hälso- och säkerhetsproblem längre fram om de inte upptäcks.• Dokumenterar inte bara det som skickats till skrivaren utan även vad som faktiskt tryckts och är dokumenterat i granskningsloggen, vilket innebär att fel kan upptäckas snabbt och åtgärdas effektivt.• Möjliggör en snabb omplacering av resurser genom att avlägsna ett moment i hanteringen och förenkla arbetsflödet• Använder simultaninspektion och nytryck i sekvens för felfri etikettering• Införlivar en enda granskningslogg för alla dina etikettproduktionsprocesser, inklusive förmågan att sammanfoga din etikettutskrift vid tidpunkten för tryck• Håller etikettinspektionen på plats så enkel som möjligt och försäkrar en divisionsövergripande organisatorisk standard LÄS VÅRT POLICYDOKUMENT FÖR ATT FÅ EN GOD UPPFATTNING OM VISIONSYSTEMEN PRISYM ID-teamet har specialistkunskaper som gör att du kan vara säker på att erhålla rätt information vad gäller design av biovetenskapliga etiketter och livscykelhantering. • 30 års erfarenhet på etiketts- och autoidentifieringsmarknaden. Vi arbetar med allt från nystartade företag till stora börsbolag• Ackrediterad som leverantör av GS1-lösningar för att försäkra våra kunder om en produktion av kompatibla GS1-streckkoder• Test i egen fabrik och ett valideringsteam för att stödja alla kompatibilitetskrav och all livscykeldokumentation• Ett erfaret konsultteam för att hjälpa dig med genomförandet av lösningar, konfigurationer och utbildning• Högutbildade specialistutvecklare konstruerar specifika skrivardrivrutiner för att garantera en snabb dataöverföring till ett brett spektrum apparater• Programsupport-service dygnet runt som smidigt hanterar ditt företags behov av allt från felsökning till uppgradering, ominstallation och konfigurationer. LÄS VÅRT POLICYDOKUMENT FÖR EXPERTRÅD  

[BLOG] Kriget mot fel

Produktåterkallningen ökar inom industrin för medicinteknisk utrustning och efterlämnar ett spår av förödelse för företagens verksamhetseffektivitet och lönsamhet. Etiketteringsfel är fortfarande en vanlig orsak till återkallelse - men det är ett fel som lätt kan undvikas.

PRISYM 360

En UDI Ready Revolution in Label Lifecycle Management - Ta en 360 ° Vy över din Label produktionsprocessen för att säkerställa FDA efterlevnad to Ensure FDA Compliance ÖVERSIKT I PRISYM 360 har vi fört samman hela vår branschkunskap, erfarenhet och kundkännedom för att skapa en förstklassig kärnlösning som lätt kan konfigureras efter ditt företags behov och som går snabbt att ta i bruk. PRISYM 360 är en kraftfull, heltäckande, skalbar och UDI-klar validerbar märkningslösning som erbjuder tillverkare av medicintekniska produkter total märkningsintegritet från datahantering till design och godkännande och hela vägen till etikettproduktion och inspektion för att motsvara de strängaste följsamhetskraven, inklusive FDA:s och EU:s regelverk. Produktåterkallelser beroende på felaktig märkning och förpackning, UDI-följsamhet, omarbetade etiketter, just-in-time-tryckning, lokala språkkrav och automatiserad märkningsinspektion (för att bara nämna några få exempel). Allt detta påverkar idag produktionsprocesserna för medicintekniska produkter. Det är lätt att förstå varför företag ägnar så stor uppmärksamhet åt märkning. Det är dock avgörande att man ser på proceduren ur ett vidare perspektiv. I kampen för att leverera säker, korrekt och följsam produktinformation handlar det inte bara om etikettens kvalitet – det handlar också om data. Med PRISYM 360 kan den kostsamma felmärkningen av medicintekniska produkter nu undvikas. Genom att tillhandahålla en 360-graders genomlysning av din organisations masterdata-tillgångar och möjligheten att styra och optimera dem för att skapa en helt integrerad strategi genom hela livscykeln, kan vi omvandla din produktions- och märkningsprocess. LADDA NER PRISYM 360 DATABLAD FÖR MER INFORMATION FUNKTIONER OCH FÖRDELARGenom att implementera PRISYM 360 får din organisation följande operationella fördelar: En enda skalbar plattform för livscykelhantering (LLM, Label Lifecycle Management) genom hela verksamheten som kan minska den kostsamma risken för produktåterkallelser på grund av felaktig märkning Stöd för tredjepartstillverkning, förpackning och märkning för att underlätta att målen för operationell effektivitet nås Stöd för FDA:s kommande följsamhetskrav gällande UDI (UDI, Unique Device Identification) Stöd för lokalt språk och landsspecifik märkning i hela världen Utnyttjande av ett globalt arbetsflöde för granskning, godkännande och versionskontroll av etikettformat och data med hög grad av synlighet och spårbarhet Livscykeldokumentation baserad på GAMP 5-modellen för att arbeta enligt cGMP genom att följa alla riktlinjer Plattform för att uppnå global standardisering av märkningslivscykeln, inklusive data, format, varumärke och arbetssätt Implementering av en harmoniserad process för att styra skapande, redigering och operationell användning av märkningsinnehåll genom hela verksamheten Konsoliderar, styr och inkluderar all förekomst av produktionsetikettryckning vid tillverkningslinjer, hos distributionscenter, samt av tredjepartstillverkare Signifikant ökad flexibilitet och kontroll av produktionsmärkning av en specifik produkt på flera platser Bättre utnyttjande av befintligt nätverk och befintliga IT-tillgångar, vilket minskar kostnaderna och skyddar tidigare investeringar i infrastruktur Svarar mot de specifika kraven för spridning och validering tack vare lågriskskonfigurering som accelererar operationell effektivitet och avkastningen på investeringar EXPERTIS PRISYM ID har specialister som ger support för din globala livscykelhantering. Vi kan redovisa resultat som uppvisar snabbt förverkligade fördelar för verksamheten och påtaglig avkastning på investeringar efter implementering hos globala organisationer Bevislig historik av programvaruinnovation som förser kunder som styrs av FDA:s och EU:s regelverk med banbrytande lösningar Yrkesskickliga serviceteam assisterar med utformning, implementering, konfigurering och utbildning för valda lösningar Yrkesskickliga valideringsexperter arbetar tillsammans med kvalitetsteam för att stödja implementeringen av en följsam livscykelhantering av märkningen i enlighet med företagets kvalitetsriktlinjer Med utveckling, testning och supportteam på plats får du en komplett heltäckande lösning från en enda leverantör Global programvarusupport dygnet runt, alla dagar i veckan Ackrediterad GS1-leverantör för att säkerställa produktion av följsamma streckkoder LADDA NER PRISYM 360 DATABLAD FÖR MER INFORMATION  

Uppnå följsamhet till UDI

Uppnå följsamhet till UDI – Det handlar om mer än att bara ändra etiketten I detta 60 minuter långa webbinarium presenterar Jay Crowley, Vice President för UDI Solutions and Services vid USDM och Hal Plant från PRISYM ID hur du på bästa sätt kan inkorporera unik produktidentifiering (Unique Device Identification, UDI) i din övergripande strategi för kvalitets-, följsamhets- och riskhantering, för att inte bara uppnå UDI-följsamhet utan också få betydande produktivitetsfördelar.Fördelar med att följa webbinariet: Förstå UDI-kraven och dina ansvarsområden Lär dig att utnyttja UDI för att minska riskerna och uppnå ny operationell effektivitet Upptäck hur du kan inkorporera UDI i din övergripande strategi för kvalitets-, följsamhets- och riskhantering Få insyn i vilken påverkan UDI har på datahanteringen SE WEBBINARIET ”ACHIEVING UDI COMPLIANCE” HÄR Att uppnå följsamhet till FDA UDI handlar inte bara om etiketten. Den är bara en av flera faktorer i den omfattande processen att effektivt hantera data i produktionen. När man ser den stora andel frivilliga återkallelser av medicintekniska produkter som beror på felaktigheter i märkning och förpackning, är det lätt att förstå varför just etiketten hamnar i fokus. Konsekvenserna av produktåterkallelse är betydande. Det slår hårt mot effektivitet, produktivitet, och avkastning, och den potentiella skadan på varumärkets anseende och patientsäkerheten är lika kännbar. Men strävan att leverera säker, korrekt och följsam produktinformation handlar inte bara om etiketten – det handlar om data. Genom att göra en 360-graders översyn kan organisationer försäkra sig om att de samlar in, lagrar och sprider data på ett säkert, snabbt och exakt sätt. Centraliserad data utgör en robust plattform för ”den enda sanningen” som kan användas för att stödja följsamhet till UDI och få en redovisningskedja, med vars hjälp man kan försäkra sig om att rätt information hamnar på rätt produkt i rätt tid, alltid.  

9 Labeling Challenges and How to Overcome Them

Tweet !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs'); #1: Multilingual Labeling – Does it really have to be so difficult? As medical device, pharmaceutical and clinical trial organizations seek to leverage existing products in new markets, or look to extend product ranges in existing geographies, the requirement to ensure that packaging is accessible to the population in that particular market has become increasingly important. Sourcing, recording, controlling, designing and using language-specific information is now critical to accessing a number of emerging markets for medical devices whether they are manufactured locally or imported to a specific geography.Medical materials are shipped across many countries and many continents. For the sake of patient safety, the ability to control these materials’ labels at a global level is paramount. Labels must therefore be safely and accurately customized not only so that they are in the appropriate local languages, but also so that country-specific labeling requirements are met. Labels must ensure nuances of country specific designs and regulatory requirements are understood sufficiently to communicate coherently with users. Any local language labeling errors can create the risk of brand damage, especially during product recalls.At PRISYM ID, we recently polled our customer base to see what the biggest challenges have been when it comes to label production. Not surprisingly, out of nine major issues, language management or multilingual labeling was the most prevalent one - across the board. Why is that? Most of the time, language management is viewed as a difficult task due to many perceived complexities. Companies may often struggle with outdated, manual processes. This then creates difficulties in dealing with the translation of individual phrases, country-specific requirements, specific local language differences… the list goes on and on.Not surprisingly, label lifecycle management solutions have become an important weapon in the language management arsenal. A proven, validated labeling software system will remove the perceived complexities of local language labeling and facilitate the management of source data for labels, all while meeting country-specific requirements. DOWNLOAD OUR INFOGRAPHIC TO SEE THE RESULTS OF OUR POLL   #2: Expansion and global labeling – Controlling the chaos The medical device industry landscape is constantly in a state of flux with billions of dollars changing hands on a daily basis. Expansions. Mergers. Acquisitions. Restructuring. Spinouts. Downsizing. New regulations. Emerging markets. It’s all enough to make your head spin.As medical device companies like yours expand by experiencing growth or through mergers and acquisitions, the affect on packaging and labeling operations can be significant. Perhaps a new geography is being introduced. Or, a new range of products is making its debut in the market. Or, perhaps your manufacturing operations are moving to 24/7 and changing to adhere to a raft of import restrictions.Regardless of the method of growth your company is experiencing, you will need to always be prepared to extend and maintain control of your manufacturing labeling process throughout and after the growth period. Many companies have chosen to standardize on a Label Lifecycle Management system in order to maintain some control throughout corporate expansion activities. Besides offering you improved label integrity and consistency, a labeling software system can help you unify and integrate your labeling efforts across new, global business units and acquired companies. A labeling software system can also improve standardization efforts on a global basis and reduce the need for manually monitoring the labeling process.   #3: Managing the complexities of global labeling requirementsAll global manufacturers, including medical device manufacturers, wrestle with country of origin labeling requirements in one way or another. It can be especially confusing and complex in an environment where kits or packs are assembled, such as instrument manufacturing, or where complex devices are sold – which may include supply components from many territories.As companies like yours expand into new manufacturing territories, country of origin labeling requirements can slow your business down if you are not adequately prepared. How can you be confident and fully prepared to meet country of origin requirements head-on? The best way is to make sure that the appropriate processes and procedures are built into the packaging and labeling process ahead of time, rather than leaving the interpretation of regulations to the production line.One way to alleviate the complexity is to be proactive about moving to a lifecycle labeling system if you haven’t done so already. A labeling software system will help you manage your data more effectively and assist with every aspect of your overall labeling process, including adherence to country of origin requirements.   Issue #4: Reduce waste and spend - Insert management on demandIt is a constant struggle for medical device, pharmaceutical and clinical trial organizations to keep on top of all the newest regulations, certifications and required updates in a timely fashion. In this day and age of ever changing policies and country-specific labelling requirements, maintaining booklets has become a cumbersome manual process ̶ and they are expensive to produce.Multipage booklets are costly for organizations to manufacture because any required change means the entire booklet needs to be updated and reprinted. The ability to print single page instructions on demand is more economical and efficient and can be version controlled. Printing IFUs on demand helps ensure you include the right information with the right product in the right language – every time.Proven benefits from current case studies show:• Stronger version control processes• Reduction in waste and space• Ease of new market adaption management• Up to $8 million in annual savings [INFOGRAPHIC] How one client saved $8M using PRISYM IDs print-on-demand solution   #5 Label Defect Control - Achieving zero-defect labelingWith the introduction of UDI, the need for medical device manufacturers to examine systems, processes and operations is intensifying. Product recalls in the medical device industry are increasing – impacting operational efficiencies and profitability. Labeling errors are a common cause of recall, but they can be easily avoided. The introduction of automated vision systems means there are more effective, efficient and secure ways of ensuring zero-defect labeling.By integrating automated vision inspection with label lifecycle management software, medical device manufacturers can manage and document labels through design, approval, print and inspection. This end-to-end approach gives greater visibility and control of the entire process, and supports FDA compliance.To find out more, watch our best practice guide to achieving zero-defect labelling. This webinar presents best practices to help: • Understand why print verification systems are becoming an essential part of the production line• Discover why your medical device label production may not be meeting FDA compliance requirements• Achieve insight into best practices for managing defect control WATCH THE VISION SYSTEMS WEBINAR HERE   #6 The 3 Cs of Label ProductionRecent UDI requirements have persuaded many medical device companies to review their labeling capabilities. This, alongside other regulatory, technological and market drivers, has led to a growing number of companies issuing Requests for Proposals (RFPs) to labeling solution vendors to address this key operational activity. However, many organizations still overlook the strategic importance of labeling and underestimate its impact right across the supply chain.Companies need to take an enterprise-level approach to determine the impact a label lifecycle management system can have in terms of operational efficiency, risk management, regulatory compliance, consolidation and in some cases expansion.All instances of production label prints across manufacturing lines, distribution centers, as well as by 3rd party manufacturers must Consolidate, Control, and Capture the entire process.The three C’s enable companies to manage electronic reconciliation across all printing operations within the system to satisfy regulatory auditors and management accountability, ensuring a “single version of the truth” to meet current and evolving regulatory requirements including UDI.By incorporating the three C’s in label lifecycle management software, medical device manufacturers can manage and document labels through design, approval, print and inspection. This end-to-end approach gives greater visibility and control of the entire process, and supports FDA compliance.   #7 Three key considerations for implementing UDIIn the ever increasing interests of patient safety and efficient protection of public health, the FDA has adopted a rule for UDI in support of enhancing safety, with the aim of identifying errors involving medical devices and providing more rapid resolution of device problems. The standardization of a common UDI mandate is designed to increase visibility and improve the quality of information in medical device adverse event reports, improve traceability and security within the supply chain. It will also reduce the potential for medical errors through consistent, unambiguous, harmonized data. Furthermore, UDI will facilitate the storage, exchange and integration of data and systems between suppliers and providers. 3 key questions for medical device manufacturers are; based on your current system capabilities: Are you able to properly control the elements and execution of your print jobs and then capture the data elements of every label printed? Will you be positioned to efficiently capture and submit the necessary UDI data to the Global UDI Database? Have you factored in the training of your staff and allocated sufficient time to integrate this additional labeling requirement to your current processes? If you can’t give a definitive yes, then you need to think about how you will manage this in the future. By planning and implementing a label lifecycle management strategy with the right processes and right solution, you will guarantee UDI readiness for your organization without derailing your production.This recent whitepaper from PRISYM ID and GS1 walks you through the necessary steps and processes to keep you on track when implementing UDI. DOWNLOAD THE WHITEPAPER UDI: GETTING AHEAD OF THE GAME     Tweet !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs');

Our Top 10 LinkedIn Posts in 2014

We're taking a look back at our most popular LinkedIn posts in 2014. We did it for intrigue, what we got was an education.  Career opportunities are unsuprisingly popular considering the forum. Articles with an image, download or a number in the opening line also got a high amount of engagement, versus articles that were text-heavy. Noted for 2015. Common industry challenges like UDI and zero-defect labeling are also high on the list. Here's our top 10, starting with the most popular: Careers at PRISYM ID 5 steps to getting the most from your label supplier  Download our UDI infographic Are you on Google+ too? Press Release: PRISYM ID is a Silver Sponsor at the Medical Devices Summit 2014 The top 9 labeling challenges The ABCs of IQ, OQ, PQ We're hiring The War on Error Labeling Challenges Blog: Achieving zero-defect labeling Read more topical blogs here. Follow us on LinkedIn where we hope to bring you even more interesting and educational articles in 2015.    

PRISYM 360 Launch

A Revolution in Labeling Today, product recalls caused by labeling and packaging defects, UDI compliance, label rework, just in time printing, local language requirements and automated label inspection (to name just a few) all have an impact on  medical device production processes. So its easy to see why companies focus so much attention on labeling. However, a broader view of the procedure is essential. In the battle to deliver safe, accurate and compliant product information, it’s not just about the quality of the label – it’s also about the data. PRISYM ID has brought together all of our industry knowledge gained by delivering labeling solutions to 12 out of the top 20 leading Medical Device Manufacturers to create an elite core solution, PRISYM 360. Providing a powerful, comprehensive, scalable and validatable solution, PRISYM 360 offers complete label integrity from data management to design and approval through to label production and inspection. With PRISYM 360, the costly mislabeling of medical devices  has become avoidable. By providing a 360° outlook of your organization’s master data assets and giving the ability to control and optimize them to create a fully integrated approach across the lifecycle, we can transform your production and labeling process into an error-free operation.               

Why Choose Us?

We can prove our solution excellence through six simple proof of points:   Point: 1 Proof of Precedence – Clients PRISYM ID has a proven track record of delivering global label lifecycle management solutions that have a fundamental impact on our clients’ manufacturing processes and distribution. Our solutions have been accepted as superior to anything else on the market and have been deployed by some of the world’s most regulated companies; companies typified by the need for compliant label management and printing solutions. Read Our Client Services Datasheet   Point: 2 Proof of Validation PRISYM ID’s professional services team engage with our clients to support every element of validation - from initial user requirements to final performance testing. Our solutions can be supplied as a validated package, including auditable security protocols and lifecycle documentation, based on the GAMP V Model. Read Our Professional Services Datasheet       Point: 3 Proof of Compliance Growing numbers of businesses need to meet industry specific labeling regulations, many demanding complete lifecycle traceability of every product. The premise may seem straight-forward, but implementing these regulations, adhering to them, and being able to document that your organization is compliant is another matter altogether. PRISYM ID’s solutions centrally manage your products label lifecycle from design, review, approve, print, inspection, reprint to reconciliation, with the peace of mind that it has purpose built user security, group security and secure audit log. Our clients meet the following industry compliance requirements and standards by using our solutions: Learn About Our New Revolutionary Compliant Labeling Solution         Point: 4 Proof of Integration Our aim is to make the implementation of our solutions simple. To deliver on this promise, we have designed our software to be technology agnostic so that our solutions can be easily integrated with existing systems such as MRP, ERP and PLM. We have developed high speed drivers for over 500+ printers and have integrated our solution with leading print inspection systems. The joint value propositions we build with our partners have one fundamental principle – to offer increased business success for our clients. Learn About Our Revolutionary End-to-end Labeling Solution                       Point: 5 Proof of Delivery – Professional Services PRISYM ID is dedicated to ensuring that we exceed our clients’ expectations when implementing our world-class labeling solutions. Our elite professional services team can add value and reduce cost at all touch-points of your label production process including project management, validation, health-checks, training and support & maintenance. Read Our Professional Services Datasheet                        Point: 6 Proof of ROI ROI comes in many forms; from cost saving, elimination of compliance fines, time saving, reduction in recalls, brand reputation to reduction in packaging and truck roll. Our clients have seen benefits from: Reduction in the risk of errors that can lead to compliance issues and product recalls Streamlined labeling processes on the operating floor Simplified management of on-demand labeling process Simplifying label design and approval process of labels including variable data Avoidance of rework due to manual errors    Learn About Our Revolutionary End-to-end Labeling Solution                  

UK Office Directions

Driving instructions to PRISYM ID, Wokingham, UK From the M4 (East or West bound): Exit M4 Junction 10 A329M towards Wokingham and Bracknell Take 1st exit for A329 Wokingham Town Centre Approaching town centre bear left onto A321 signposted Sandhurst and Camberley Follow A321 through Town Centre Go under 2nd railway bridge At mini roundabout take 2nd exit onto Molly Millar's Lane At mini roundabout take 1st exit into Fishponds Road Road bends sharp left into Oaklands Park Turn right after the 'Trademark Windows' building into a cul de sac * TECH House is the building to your right From the M3: Exit junction 3 Follow A322 signposted Bracknell After approx 1.5 miles the dual-carriageway forks - bear left for A322 Bracknell At the 4th roundabout take 2nd exit and follow A322 Wokingham At the 'Twins Bridge' roundabout take the 2nd exit and follow A329 for Wokingham At roundabout proceed straight ahead for A329 Wokingham Take first exit for A329 Wokingham Town Centre Continue from bullet point 4 above By Rail: Wokingham station receives regular services from London Waterloo and Reading

Legal Notice

PRISYM ID Legal Notice The information contained in this website is given in good faith for general information only and is subject to change without notice. PRISYM ID uses reasonable efforts to ensure its accuracy but makes no representation and gives no warranty as to its accuracy or otherwise. To the fullest extent permitted by law all such representations and warranties whether expressed or implied are excluded. Nothing in this website is intended to be nor should it be construed as being an offer to enter into a contractual relationship.PRISYM ID accepts no liability for any loss or damage howsoever arising, whether direct, indirect, special or consequential, which may be suffered by any person in accessing, downloading, using or relying on any information or other materials contained in this website, save that nothing in this notice shall restrict or exclude the company's liability for death or personal injury resulting from PRISYM ID negligence of for fraud or to the extent otherwise not permitted by law. If you wish to link to this website, please contact us at \n This email address is being protected from spambots. You need JavaScript enabled to view it. for more details.PRISYM ID Limited - Labeling, RFID and Barcode Solutions for Product Lifecycle ManagementREG No.:5004963 VAT No.: 849 7492 63

Terms & Conditions

PRISYM ID LIMITED Terms & Conditions These Terms & Conditions of Supply demonstrate our commitment to your personal information. The following sets out our information gathering and dissemination practices for this website. If you have any questions or queries regarding these terms & conditions, please contact \n This email address is being protected from spambots. You need JavaScript enabled to view it. TERMS AND CONDITIONS OF SUPPLY 1. INTERPRETATION 1.1 In these terms and conditions: "AO" means the acknowledgement of order form (if any) issued by the Company to the Purchaser;"Applicable Guarantee Period" means in relation to any Goods the guarantee period applicable to those Goods subject to clauses 7.3 and 7.4 as notified in the relevant quotation issued by the Company and confirmed in any AO or if not stated therein shall be 90 days from the date of delivery;"Contract" means the agreement between the Purchaser and the Company for the supply of the Goods and / or Services;"Goods" means the goods and/or services (as appropriate) listed in the AO or which the Company otherwise agrees to supply to the Purchaser (including any instalments or parts of the goods);"liability in relation to" means "liabilities, losses, damages, costs (including without limitation legal costs on a full indemnity basis and value added tax and other applicable taxation), expenses, actions, claims, proceedings and demands whatsoever arising directly or indirectly out of or in connection with";"Purchaser" means the purchaser of the Goods as stated in any applicable AO;"Price", subject to these Terms, means the price for the Goods as quoted and confirmed in any AO."Services", means any services which PRISYM ID agrees to perform as specified in the AO; 1.2 Any Contract provision invalid or unenforceable for any purpose shall be severed for that purpose but otherwise remain valid and enforceable and shall not affect the validity of the remainder of the Contract. 1.3 A payment shall be deemed made when credited to the payee's bank account and is cleared funds. 1.4 Save as otherwise agreed in writing by the Company the Contract shall comprise solely these Terms, any AO and any relevant quotation issued by the Company to the Purchaser. Variations of the Contract shall be effective only if agreed in writing and will then prevail over these Terms. 2. QUOTATIONS, SPECIFICATION, VARIATION AND CANCELLATION 2.1 A quotation is not an offer and may be withdrawn or modified; save as otherwise agreed in writing by the Company no contract or commitment shall exist until the Company sends its AO to the Purchaser or until the Company commences work on or appropriates Goods to the Contract or commences performance of Services. 2.2 The Company may alter the specification of any Goods or the scope of any Services if this does not materially affect their performance or utility. 2.3 If any variation in the Goods, Services or the Contract is agreed or is required for compliance with any applicable law, regulation or safety recommendation the Purchaser shall pay such additional amount as is fair and reasonable and the Company shall have reasonable additional time to perform the Contract. 3. PRICES AND PAYMENT 3.1 Subject to any AO, the Price shall be ex-works and shall exclude value added tax and any other applicable taxes and duties, packaging, carriage, insurance, documentation and installation charges. Unless costed for in any AO, the Company may make reasonable additional charges for complying with any special requirements of the Purchaser. Payment, subject to any AO, shall be made in sterling clear of any banking transaction charges and without any deduction, set off or counterclaim whatsoever. Payment shall be made in accordance with the payment terms stated in any AO, or if none are stated, within 30 days of invoice following delivery of the Goods or performance of the Services. 3.2 Time of payment is of the essence of every Contract. Without limiting the Company's remedies if payment is overdue, the Purchaser shall indemnify the Company against any legal fees and other costs of collection and (as well after as before judgment) shall pay to it a sum equal to any loss suffered by the Company arising from exchange rate fluctuations and interest on such sum and on the amount overdue at 4% above the base rate from time to time of Barclays Bank PLC calculated from the date payment fell due until the date of actual payment (or such lesser amount as is the maximum rate permissible by law) and the Company may cancel the Contract and any other contracts and suspend deliveries to the Purchaser. 3.3 Any payment which falls due later than it would have done because of delay caused by the Purchaser shall be deemed to fall due when, but for the Purchaser's delay, it might reasonably be expected to have fallen due. The Company may delay or withhold performance under the Contract until the Purchaser has made any payment or opened any letter of credit or established any other payment arrangements which are due to be made, opened or established and its time for performance shall be extended accordingly. 4. RISK AND PROPERTY 4.1 Until payment has been made of the whole of the Price and other monies payable by the Purchaser under the Contract and of all other monies owing by the Purchaser to the Company at the time the payment for the Goods falls due: (a) property in any Goods shall remain the Company's; the Purchaser shall hold such Goods as the Company's fiduciary agent and bailee, stored separately from those belonging to any other person and labelled so as to show clearly that they are the property of the Company and properly protected, treated and insured;(b) the Company may recover and/or resell the Goods, require their return to the Company and enter upon the Purchaser's or any carrier's premises by its servants or agents for that purpose and the Purchaser grants the Company an irrevocable licence to this effect which shall survive termination of the Contract;(c) upon disposal by the Purchaser of the Goods it shall account to the Company for the proceeds and shall keep such proceeds separate from any other monies or property and (if tangible) properly stored and insured;(d) the Company shall have a right of lien over any goods or materials belonging to the Purchaser which are in the Company's possession or control; and(e) the Purchaser shall not pledge or charge by way of security for any indebtedness any of the Goods which remain the Company's property but if it does all monies owing by the Purchaser to the Company shall forthwith become due and payable. 4.2 Risk of damage to or loss of the Goods shall pass to the Purchaser at the earlier of the time when the Company notifies the Purchaser that the Goods are available for collection or upon the Company first despatching the Goods from its premises 5. DELIVERY 5.1 Save as otherwise agreed in writing by the Company delivery shall be made by the Company making the goods available for collection from its premises and so informing the Purchaser or, if some other place for delivery is stated in any AO, by the Company or its nominated carrier despatching the Goods from its premises to the stated place. If the Purchaser fails to take delivery or to give adequate delivery instructions, the Company may (without prejudice to its other rights) store or dispose of the Goods, in which case the Purchaser shall pay to the Company upon request the amount of any reasonable storage or disposal charges. Whilst the Company will seek to meet the stated delivery time, it is approximate and the Company shall not incur liability in relation to late delivery. If no time for delivery is agreed the Purchaser shall accept the Goods when ready for delivery. 5.2 The Company may deliver in instalments constituting separate contracts and delay in delivery of any instalment will not entitle the Purchaser to terminate the Contract, nor permit the set off of any payments in respect of one delivery against any claim in respect of any other delivery. Where Goods are delivered by instalments the Company may issue separate invoices. 5.3 The costs of clearing the Goods for export from the UK and import into the country of delivery shall be borne by the Purchaser unless any AO states otherwise; the Purchaser shall clear the Goods for any subsequent export or use and shall comply with the Company’s reasonable instructions in relation to export controls; the Purchaser shall indemnify the Company against any liability in relation to any breach by the Purchaser of this clause 5.3. 6. INSPECTION AND ACCEPTANCE The Purchaser shall inspect and test the Goods and within 7 days of their delivery (and in respect of Services, within 7 days of the Company tendering their completion) shall give written notice to the Company of any damage or claim. In the absence of such notice, the Goods shall be deemed to comply with the Contract and the Purchaser shall accept them. The Goods are sold as a batch and without prejudice to the Purchaser's right to reject all the Goods the Purchaser may not reject some only of the Goods. 7. GUARANTEE 7.1 Subject to clause 7.5, if within the Applicable Guarantee Period any Goods prove defective by reason of faulty design, workmanship or materials the Company will adjust, repair or replace them as it sees fit free of charge provided that: (a) the Purchaser gives written notice of the defect (with reasonable relevant information) to the Company as soon as reasonably practicable and within the Applicable Guarantee Period;(b) the Goods have been used solely for their proper purpose and in accordance with the operating instructions;(c) the defect has not been caused by fire, accident, misuse, neglect, incorrect installation by the Purchaser or its customers, agents or servants, unauthorised alteration, repair or maintenance or the use of sub-standard consumables and has not arisen from fair wear and tear;(d) the defect has not arisen from any design, specification, component or material supplied by or on behalf of the Purchaser;(e) no part of the Goods have been replaced with a part not supplied or approved by the Company, nor have the Goods been altered or modified by any person other than the Company;(f) payment in full of all sums due in respect of the Goods has been made;(g) the Purchaser shall be liable for any costs incurred by the Company in responding to claims caused by operator error or incorrect application or other default of the Purchaser or other third party;(h) the Purchaser shall accord the Company sufficient access to the Goods to enable its staff to inspect and adjust, repair, remove or replace the Goods;(i) the costs of all consumables (including but not limited to paper, gel, ink etc) shall be paid by the Purchaser. 7.2 The Company may repair the Goods in situ or have them returned to its premises; if the latter, the risk in the Goods shall at all times remain the Purchaser's and they shall be packaged as the Company instructs and despatched at the Company's expense. Costs of carriage on the Goods' return to the Purchaser shall be borne by the Company where the defect is covered by this guarantee. 7.3 If the Goods or Services incorporate goods or services provided by a third party, the obligations of the Company in respect of such goods or services shall not exceed the warranty obligations of such third party to the Company nor exceed any time limit upon those obligations; 7.4 The Applicable Guarantee Period for any Goods replaced or repaired or any corrective services pursuant to the initial guarantee shall be the remaining period, if any, of such initial guarantee period. 7.5 To the extent that the Goods comprise labels, the Company uses all reasonable endeavours to meet specifications, but absolute compliance with specification is not guaranteed and all supplies of labels are subject to the following: (a) delivery quantities, label sizes, specifications and designs are subject to variations of up to 20% either way in respect of each item and each aspect;(b) reproductions of designs are subject to variations of up to 2mm in length and / or width; and(c) colour fastness and non-shrinkage are not guaranteed and colour matches are subject to the best commercial match reasonably available 8. EXCLUSION AND LIMITATION OF LIABILITY 8.1 In an effort to keep the contract price as low as possible and as the Purchaser is better able than the Company to quantify loss which it may suffer from a breach of contract and to insure accordingly, the Purchaser agrees to the Company limiting its liability and therefore agrees that save as expressly agreed in writing or as mandatorily implied by law: (a) the Company shall have no obligation in respect of the Goods except for its undertaking in clause 7 above ("the Guarantee") and as expressly stated in the Contract;(b) if the Company has repaired or replaced the Goods pursuant to the Guarantee, it shall have no further liability in respect of such defect or fault in the Goods;(c) the Purchaser acknowledges that the Company’s obligations and liabilities in respect of the Goods are exhaustively defined in these Terms and that such express obligations are in lieu of and to the exclusion of any other warranty, condition, term, undertaking or representation of any kind, express or implied, statutory or otherwise relating to the Goods including, without limitation, as to the condition, quality, performance or fitness for the purpose of the Goods or any part of them;(d) the Company shall not be liable for any loss which represents loss of profit, revenue, loss of anticipated benefit, anticipated savings or goodwill, loss of use of any asset, loss of data, business interruption, management costs or third party liability 8.2 The aggregate liability of the Company (whether in contract, tort, breach of statutory duty or otherwise) for all breaches under or non-performance of its obligations or contemplated by any Contract shall not exceed a sum equal to one and a half times the amount paid for any Goods or Services the subject of such Contract save that this sub-clause shall not limit or exclude any liability of the Company which cannot be effectively excluded in law 8.3 The Purchaser shall not rely upon any representation concerning the Goods or Services unless made by the Company in writing in the Contract save that nothing in the Contract or theses Terms shall exclude liability for fraudulent misrepresentation. 8.4 Save to the extent of any warranty stated or expressly confirmed in the AO (and so far as permitted by law), the Company shall have no liability in respect of any failure by the Goods to recognise date changes and the Purchaser shall satisfy itself in all such respects. 8.5 Any liability of the Company under any warranty, indemnity or other obligation stated or confirmed in the AO is subject to all exclusions and limitations in these Conditions. 9. REGULATORY COMPLIANCE AND LICENCES 9.1 The Goods will comply with mandatory United Kingdom ("UK") regulations applicable to the production and non-consumer sale of the Goods at the date of delivery but no other warranty or undertaking as to regulatory or legal compliance in the UK or elsewhere is given or to be implied unless specifically given in writing signed by a director of the Company or stated in any AO. The Purchaser shall comply with applicable laws relating to the Goods, their use and disposal. 9.2 The Purchaser shall obtain in good time any applicable licences, permits and approvals relating to import and export and to the installation and/or operation of the Goods and will indemnify the Company against all liability in relation to Goods supplied without them. The Company shall not be responsible for any liability in relation to delay in obtaining or failure to obtain such licences, permits or approvals. 10. TERMINATION OF CONTRACT 10.1 The Company may terminate separately all or any of the Contract and every other contract with the Purchaser if: (a) the Purchaser fails to make payments to the Company under any contract as they fall due or the Purchaser otherwise breaches any such contract and the breach or non-payment is not remedied within seven days of notice from the Company; or(b) the Purchaser is, or is deemed to be, insolvent or suspends payment or performance of its obligations or threatens to do so, or the Company has reasonable grounds for believing it will fail to discharge its obligations under any contract or steps are taken to propose any composition, scheme or arrangement involving the Purchaser and its creditors or obtain an administration order or appoint any administrative or other receiver or manager in relation to, or put in force any legal process against, the Purchaser or any of its property or enforce any security over the Purchaser's property, or repossess any goods in its possession or wind up or dissolve the Purchaser, or sequestrate its estate or dissolve it or file a petition in bankruptcy or other relief from creditors; or(c) control of the Purchaser passes from the present shareholders, owners or controllers to other persons whom the Company in its absolute discretion regards as prejudicial to its reasonable interests; or(d) in the reasonable opinion of the Company the Purchaser has ceased or threatened to cease to trade; or(e) where the Purchaser is an individual or partnership, he or any partner dies or any steps are taken with a view to making a bankruptcy order against him or any partner; or(f) anything corresponding to any of the above occurs outside England and Wales 10.2 If the Contract is terminated, the Company (without prejudice to its other rights but subject to any relevant mandatory laws) may do any of the following: (a) declare immediately payable (and so interest-bearing under clause 3.2) any sums owed by the Purchaser, proceed against the Purchaser for the same and/or damages, and appropriate any payment by the Purchaser as the Company thinks fit (notwithstanding any purported appropriation by the Purchaser); (b) suspend further performance of any Contract and/or any credit granted to the Purchaser on any account (and the time for delivery by the Company shall be extended by the period of such suspension);(c) take possession of and deal with (including the sale of) any materials and other assets of the Purchaser held by or on behalf of the Company and apply any proceeds of sale in payment of any sums owing under or damages arising in connection with any Contract including any interest and costs arising thereon. 11. INTELLECTUAL PROPERTY AND CONFIDENTIALITY 11.1 The Company retains ownership of all inventions, designs, copyrights and processes and all and any other intellectual / industrial property rights whether or not registered or registerable and all goodwill associated thereto relevant to the Goods and all specifications, designs, programs or other material issued by or on behalf of the Company. The Purchaser acknowledges that any such item is confidential and agrees not to use it or any other confidential information of the Company for any purpose (other than the purpose for which it was disclosed) nor reproduce it in any form nor disclose it to third parties. The Purchaser shall not copy the Goods nor seek to abstract from the Goods any confidential information regarding their design, construction or otherwise (and without limitation to the foregoing shall not decompile, reverse engineer, reverse assemble or copy - except to the extent permitted by applicable law - any software comprised in the Goods) and all rights subsisting in such material are reserved. 11.2 The Purchaser shall obtain similar undertakings as those set out in sub-clause 11.1 from its customers and indemnify the Company against any liability in relation to any failure to do so. The Purchaser shall upon request sign and/or require its customers to sign the Company's form of non-exclusive licence to use programs contained in or comprising or necessary to operate the Goods; all obligations of the Company under any contract are conditional upon execution of such agreement and compliance with its terms. 12. FORCE MAJEURE The Company shall not be liable for any failure to perform its obligations hereunder by reason of any cause whatsoever beyond its control (including without limitation trade dispute; fire, flood or act of god; armed conflict; equipment or supply difficulties; any rule or action of any public authority; transportation delays; refusal or delay in granting any necessary licence or permit; or any repudiatory event by the Purchaser). In such circumstances it may terminate the Contract whereupon the Purchaser shall pay a sum equal to the costs to the Company of performing the Contract and the Company's liability shall be limited to repayment of any sums paid in respect of undelivered Goods (or unperformed services) less such costs. 13. USE OF GOODS AND SAFETY 13.1 The Purchaser shall: (a) procure that the Goods (including any goods the subject of services) are used only for the purposes and in the manner for which they were designed and supplied; that all persons likely to use or come into contact with the Goods receive appropriate training and copies of applicable literature supplied by the Company; that all third parties who use or may be affected by or rely upon the Goods are given full and clear warning of any hazards (both patent and latent) associated with them or limitations of their effectiveness and that safe working practices are adopted and complied with. Any warning or proprietary notices displayed on the Goods must not be removed or obscured; the Purchaser shall procure that any third party to whom the Goods are supplied agrees not to remove or obscure such warning or proprietary notices and shall take such steps as are reasonable to enforce such agreement;(b) promptly comply with any safety recommendation made to it in respect of the Goods (including recall of them) and shall procure compliance by all relevant persons and shall pay the Company's reasonable charges for additional or replacement parts (including installation costs) supplied by the Company for this purpose;(c) maintain and make available to the Company all records necessary to enable Goods to be traced to their ultimate buyer or user;(d) indemnify the Company against any liability in relation to any breach of the Purchaser's obligations under this clause 13.1. 13.2 If Services are performed by the Company’s representatives on any premises of the Purchaser, the Purchaser shall ensure that such premises comply with all applicable health and safety regulations and that any necessary security or safety notices are communicated to the Company’s representatives. The Purchaser shall notify the Company in advance of the nature of any materials or other items to be held or worked on by the Company under the Contract, shall provide adequate warnings and instructions where such materials or items are or may be hazardous to safety and shall ensure that they comply with any requirements or descriptions in these Conditions and any AO 13.3 The Purchaser shall indemnify the Company for any loss, damage or claim which arises from or relates to such premises, materials or items and which could not have been prevented by the Company or its representatives acting in accordance with the Purchaser’s reasonable written instructions and was not caused by the negligence or wilful default of the Company or its employees. 14. GENERAL 14.1 The Purchaser shall indemnify the Company against all liability in relation to any specification, design, information or component which the Purchaser has supplied to the Company and warrants that the use of such specifications, designs, information or components will not infringe the rights of any third party. 14.2 No indulgence, forbearance, partial exercise of any right or remedy or previous waiver by a party shall prejudice any of its rights or remedies. Remedies shall be cumulative and no choice of remedy shall preclude any other remedy. 14.3 The Purchaser shall not assign, mortgage, charge, sub-let, sub-licence or otherwise dispose of the Contract or any rights thereunder in whole or in part except as expressly agreed by the Company in writing. 14.4 After termination (howsoever caused) or cancellation, clauses 3.2, 4, 8, 11, 13 and 14.1 shall continue in full effect. 14.5 A person who is not a party to the Contract has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of the Contract but this does not affect any right or remedy of a third party which is available apart from that Act. 14.6 All Contracts shall be governed and construed in accordance with English law and the Purchaser irrevocably submits to exclusive jurisdiction of the Courts of England without prejudice to which the Company may apply for any provisional or conservatory measures or interim relief in any court having jurisdiction in the Purchaser's country or the country where the Goods are then located.

Privacy Policy

PRISYM ID Privacy Policy This Privacy Policy ("Policy") demonstrates our commitment to the privacy of your personal information. The following sets out our information gathering and dissemination practices for this website. If you have any questions or queries regarding this policy, please contact \n This email address is being protected from spambots. You need JavaScript enabled to view it. We will do our best to deal with your questions or queries as soon as possible. Privacy Legislation PRISYM ID is subject to UK and European and privacy legislation, which regulates the use of individuals' personal information. This legislation imposes specific requirements on PRISYM ID and ensures that your personal information will only be used in accordance with this Policy. Data Use We will not normally ask visitors to this website to reveal any personal information. However, we will collect some data about visitors including but not limited to IP addresses and details of the web browser and domain name each visitor uses. We will ask visitors who register with us ("Users") to supply us with personal data as defined in the Data Protection Act 1998 including but not limited to names and contact details. PRISYM ID does not gather any more information about Users without their knowledge and active participation and permission than as is set out in this Policy. You agree that we may use your personal information supplied via this Website to keep you informed of any activities undertaken by PRISYM ID which we believe may be of interest to you. Part of our use of your personal information may include sending you e-mail messages. If you do not wish to receive messages please notify us by e-mail at the address at the end of this Policy. Cookies We may sometimes use an Internet file called a cookie to store login or other information on your computer. A cookie is a small piece of information stored by your browser on your computer's hard drive. Cookies are used to make the link between you and the information you have provided to the website, to identify users and personalise their visit by customising web pages for them. Most Websites automatically accept cookies although you do not have to. If you disable cookies from your browser, you may not be able to access certain features of our website. Security of Personal Information We recognise the need to ensure that personal information gathered via this website remains secure. Our site has security measures in place to protect against the loss, misuse and alteration of the personal information under our control. You acknowledge that although we exercise adequate care and security there remains a risk that information transmitted over the Internet and stored by computer may be intercepted or accessed by an unauthorised third party. Transmission of Personal Information PRISYM ID will not transfer your personal information to third parties without prior consent from you. Legal Disclosure In some cases we may be required to disclose your personal information to comply with legal requirements. Changes and Information Should you wish to have your information updated or corrected, please contact \n This email address is being protected from spambots. You need JavaScript enabled to view it. Updates to Privacy Policy We may update this Policy at any time without notice. Updates will be marked with a new edition number and dated accordingly. You agree to be bound by the Policy then in force as it appears on our website.

About Us (2)

About Us Labeling Software that covers the complete spectrum of label lifecycle management PRISYM ID design and deliver powerful, validated labeling software solutions for organizations that need complete product auto-identification and lifecycle traceability. With expertize in delivering enterprise solutions to sectors including life sciences, healthcare, automotive, chemical and industrial manufacturing, the company boasts a comprehensive range of labeling software (and consumables) to meet industry-specific compliance regulations. Specifically the company’s core customer base is within the medical device market that is subject to the USA’s strict FDA rules. Our flagship product, PRISYM Medica, is the only purpose-designed enterprise label management solution on the market for organisations that need to meet FDA 21 CFR Part 11 compliance; a requirement for any medical device organisation who trades to and within the United States. PRISYM ID has offices in the USA and Europe as well as Downloads PRISYM ID has a comprehensive range of brochures, case studies, whitepapers and newsletters to keep you up-to-date on our labeling software and to share our extensive knowledge of the latest developments within the label lifecycle management marketplace. Brochures & Datasheets Case Studies Webinars Whitepapers Newsletter Sign-Up Careers PRISYM ID is an exciting and dynamic company to join. As leaders in the global validated labeling software marketplace, we deliver competitive advantage to our customers through technical innovation, market understanding and strong deliverance. Below are listed our current job vacancies. In the absence of any specific vacancies, we are happy to receive CVs / resumes from experienced, qualified individuals who feel they could make a positive contribution to the continued development and success of our business. Please send your CV / resume, with a covering letter, to \n This email address is being protected from spambots. You need JavaScript enabled to view it. Consumables Custom labels to meet your specifications PRISYM ID’s consumables division specializes in self-adhesive, industrial, custom labels. Whether you are looking for plain self-adhesive labels, pre-printed labels, thermal transfer ribbons and print heads, holograms, RFID tags or label printers and scanners; the team will identify a product to meet your needs. The dedicated team specialize in supplying a supreme range of validated label stocks and consumables to meet your exact industry label specification and guarantee quality as a pre-requisite. Variable sizes, shapes, logos, graphics and finishes Security labels, holograms, hotfoils and seals Fan folded, on roll or part printed labels Zebra, Sato and Intermec printer specialists For more information, please contact the PRISYM ID team or visit our consumables website: www.prisymlabels.co.uk

Generic

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Headquartered in the United Kingdom, PRISYM ID has offices in the USA and Europe as well as a strategic network of partners to meet our customers’ needs on a global scale. www.prisymid.com   {article 456}...{/article}

Services

Customer Portal Please enter your log-in details below to enter the PRISYM ID customer area, where you will be able to log support queries and access useful product information. Support Services With sites in Europe and the United States, PRISYM ID is capable of delivering a high level of international support to our customers across their labeling software and hardware. Our support team consists of experienced and dedicated engineers who are committed to delivering the support services you need. With 24/7 support capabilities you have the peace of mind knowing you will have an engineer dealing with your query within a fixed time frame to resolve the problem, ensuring minimum down time , which is critical to any labelling process. Software Support We offer software support services that will seamlessly manage your company’s needs from troubleshooting to upgrades, re-installation, and configurations. PRISYM ID's software support services include: Dedicated hotline Onsite software support SLA levels to suit your requirements 24/7 support options Onsite customer training   Hardware Maintenance From troubleshooting to spare parts and repairs, training, and configurations; our team of qualified engineers have the knowledge and expertise to maintain your label printing hardware from all the industry leading manufacturers including SATO, TEC, Zebra, Astromed, Intermec, Avery, Printronix, Symbol and Datamax, to name a few. A full list can be found here. PRISYM ID’s hardware support services cover: Dedicated hotline Onsite software support High stock levels of spares for fast fix times SLA levels to suit your requirements 24/7 support options Onsite customer training Training PRISYM ID offers training services that are tailored to suit your individual requirements, whether it is to improve your technical knowledge around label management or to assist you with a project delivery. Sessions are organized into theoretical training followed by practical hands-on work to ensure an understanding of how the PRISYM ID label solutions function. These training sessions can range from 1 to 6 days, and can either be arranged on-site or at PRISYM ID’s premises.If you would like to receive more information about either training or support on any of our labeling products, please contact a member of the team who will be happy to assist you with your request.

Consumables

Custom Labels To Meet Your Specifications PRISYM ID’s consumables division specializes in self-adhesive, industrial, custom labels. Whether you are looking for plain self-adhesive labels, pre-printed labels, thermal transfer ribbons and print heads, holograms, RFID tags or label printers and scanners; the team will identify a product to meet your needs. The dedicated team specializes in supplying a supreme range of validated label stocks and consumables to meet your exact industry label specification and guarantee quality as a pre-requisite. Variable sizes, shapes, logos, graphics and finishes Security labels, holograms, hotfoils and seals Fan folded, on roll or part printed labels Zebra, Sato and Intermec printer specialists For more information, please contact the PRISYM ID team or visit our consumables website: www.prisymlabels.co.uk

Resources

Complimentary Downloads, Brochures, Case Studies and Whitepapers PRISYM ID has a comprehensive range of brochures, case studies, whitepapers and newsletters to keep you up-to-date on our labeling software and to share our extensive knowledge of the latest developments within the Label Lifecycle Management (LLM) marketplace. Brochures & Datasheets - below Case Studies Webinars Whitepapers Newsletter Sign-Up Medical DevicePRISYM Medica [DATASHEET] PRISYM Medica [WHITEPAPER] How to Ensure FDA Compliance[WEBINAR WATCH-BACK] The Compliance Crackdown: Guarding Against FDA Action[INFOGRAPHIC] An Insight to Customers Top Labeling Challenges[INFOGRAPHIC] The FDAs UDI Initiative – A Definitive Guide Vision Inspection Systems [WHITEPAPER] Vision Systems 2012[WEBINAR WATCH-BACK] Label Production Under the Microscope[DATASHEET] PRISYM Vision[VIDEO] PrintInspector Demo[DATASHEET] PRISYM PrintInspector [INFOGRAPHIC] Label Inspection Systems - Can They Safeguard Against Product Recalls?[VIDEO] Label Inspection Systems - Can They Safeguard Against Product Recalls?[INFOGRAPHIC] The FDAs UDI Initiative – A Definitive Guide PRISYM 360 [INFOGRAPHIC] PRISYM ID EU MDR[BROCHURE] PRISYM 360[WEBINAR WATCH-BACK] A Revolution in Label Lifecycle Management - Taking a 360° View[WHITEPAPER] Aligning for Growth - The Evolution of Medical Device Labeling[INFOGRAPHIC] An Insight to Customers Top Labeling Challenges[INFOGRAPHIC] The FDAs UDI Initiative – A Definitive Guide[INFOGRAPHIC] PRISYM ID UDI Lessons Learnt for EU MDR PharmaceuticalPRISYM Pharmaceutical [WHITEPAPER] Time To Act Serialization[DATASHEET] PRISYM Pharmaceutical [WEBINAR WATCH-BACK] Dropping the Gavel on Counterfeit Drugs[FREE LABEL SOFTWARE TRIAL] PRISYM Pharmaceutical [INFOGRAPHIC] An Insight to Customers Top Labeling Challenges Clinical TrialsPRISYM ClinTrial [WEBINAR WATCH-BACK] Controlling Clinical Trials Labeling on a Global Scale[DATASHEET] PRISYM ClinTrial[WHITEPAPER] Mind Your Language - Clinical Trials Labeling[INFOGRAPHIC] An Insight to Customers Top Labeling Challenges[VIDEO] Label Inspection Systems - Can They Safeguard Against Product Recalls?[BROCHURE] Overcoming the Top 5 Challenges for on demand labeling ChemicalPRISYM Chemica [DATASHEET] PRISYM Chemica [WEBINAR WATCH-BACK] The GHS Countdown – Are You Prepared for the June 2015 deadline?[WEBINAR SLIDES] The GHS Countdown – Are You Prepared for the June 2015 deadline?[WEBINAR Q&A] The GHS Countdown – Are You Prepared for the June 2015 deadline?[VIDEO] Label Inspection Systems - Can They Safeguard Against Product Recalls? Manufacturing & RetailPRISYM Design [DATASHEET] PRISYM Design [WEBINAR WATCH-BACK] PRISYM Design 6 Overview[FREE LABEL SOFTWARE TRIAL] PRISYM Design PRISYM Enterprise [DATASHEET] PRISYM Enterprise [FREE LABEL SOFTWARE TRIAL] PRISYM Design[WHITEPAPER] Aligning for Growth - The Evolution of Medical Device Labeling[VIDEO] Label Inspection Systems - Can They Safeguard Against Product Recalls? WebinarsPRISYM Design 6 Overview [DATASHEET] PRISYM Design [WEBINAR WATCH-BACK] PRISYM Design 6 Overview[FREE LABEL SOFTWARE TRIAL] PRISYM Design Going Global: Best Practices for Managing Evolving Labeling Requirements [DATASHEET] PRISYM Enterprise [DATASHEET] PRISYM Medica [WEBINAR WATCH-BACK] Going Global - Best Practices for Managing Evolving Labeling Requirements[INFOGRAPHIC] An Insight to Customers Top Labeling Challenges Automotive Component Labeling: How NSK Uses Technology to Accelerate Just-In-Time Deliveries [DATASHEET] PRISYM Enterprise [WEBINAR WATCH-BACK] Automotive Component Labeling Label Production Under the Microscope [DATASHEET] PRISYM Medica [WHITEPAPER] Vision Systems 2012[SURVEY] Vision Systems [WEBINAR WATCH-BACK] Label Production Under the Microscope The Compliance Crackdown: Guarding Against FDA Action [DATASHEET] PRISYM Medica [SURVEY] Evaluating FDA 21 CFR Part 11 Compliance [WHITEPAPER] How to Ensure FDA Compliance[WHITEPAPER] Time To Act Serialization[WEBINAR WATCH-BACK] The Compliance Crackdown: Guarding Against FDA Action Ensuring FDA Compliance: The Essential Guide to FDA 21CFR Part 11 [DATASHEET] PRISYM Medica [SURVEY] Evaluating FDA 21 CFR Part 11 Compliance [WHITEPAPER] How to Ensure FDA Compliance[WEBINAR WATCH-BACK] FDA 21CFR Part 11 Dropping the Gavel on Counterfeit Drugs [DATASHEET] PRISYM Medica [WHITEPAPER] Time To Act Serialization[DATASHEET] PRISYM Pharmaceutical [SURVEY] Serialization [WEBINAR WATCH-BACK] Dropping the Gavel on Counterfeit Drugs[FREE LABEL SOFTWARE TRIAL] PRISYM Pharmaceutical Closing the Loop - Increasing Patient Safety in the Operating Theatre [DATASHEET] PRISYM Pharmaceutical [WEBINAR WATCH-BACK] Closing the Loop - Increasing Patient Safety[FREE LABEL SOFTWARE TRIAL] PRISYM Pharmaceutical The GHS Countdown – Are You Prepared for the June 2015 deadline? [DATASHEET] PRISYM Labels[DATASHEET] PRISYM Chemica [WEBINAR WATCH-BACK] The GHS Countdown – Are You Prepared for the June 2015 deadline?[WEBINAR SLIDES] The GHS Countdown – Are You Prepared for the June 2015 deadline?[WEBINAR Q&A] The GHS Countdown – Are You Prepared for the June 2015 deadline? Vision Inspection – Managing Label Defect Control [WHITEPAPER] Vision Systems[VIDEO] PrintInspector Demo[INFOGRAPHIC] An Insight to Customers Top Labeling Challenges[VIDEO] Label Inspection Systems - Can They Safeguard Against Product Recalls?Vision Inspection Webinar Tips for Implementing FDA UDI without Derailing Production [WEBINAR SLIDES] Tips for Implementing FDA UDI without Derailing Production[WEBINAR Q&A] Tips for Implementing FDA UDI without Derailing Production[WEBINAR WATCH-BACK] Tips for Implementing FDA UDI without Derailing Production[INFOGRAPHIC] An Insight to Customers Top Labeling Challenges Controlling Clinical Trials Labeling on a Global Scale [WEBINAR WATCH-BACK] Controlling Clinical Trials Labeling on a Global Scale[WEBINAR Q&A] Controlling Clinical Trials Labeling on a Global Scale[WHITEPAPER] Mind Your Language - Clinical Trials Labeling Mind Your Language; Controlling Labeling on a Global Scale [WHITEPAPER] Mind Your Language - Clinical Trials Labeling[BROCHURE] PRISYM 360[WEBINAR WATCH-BACK] Mind Your Language; Controlling Labeling on a Global Scale[INFOGRAPHIC] An Insight to Customers Top Labeling Challenges A Revolution in Label Lifecycle Management - Taking a 360° View [BROCHURE] PRISYM 360[WEBINAR WATCH-BACK] A Revolution in Label Lifecycle Management - Taking a 360° View[WEBINAR Q&A] A Revolution in Label Lifecycle Management - Taking a 360° View[INFOGRAPHIC] An Insight to Customers Top Labeling Challenges Boston Scientific Share Advice on Streamlining End-to-end Label Lifecycle Management [BROCHURE] PRISYM 360[WEBINAR WATCH-BACK] Boston Scientific Share Advice on Streamlining End-to-end Label Lifecycle Management[WEBINAR SLIDES] Boston Scientific Share Advice on Streamlining End-to-end Label Lifecycle Management[WEBINAR Q&A] Boston Scientific Share Advice on Streamlining End-to-end Label Lifecycle Management[INFOGRAPHIC] An Insight to Customers Top Labeling Challenges Achieving UDI Compliance – More Than Just a Label Change [BROCHURE] PRISYM 360[INFOGRAPHIC] An Insight to Customers Top Labeling Challenges[WEBINAR WATCH-BACK] Achieving UDI Compliance – More Than Just a Label Change[WEBINAR SLIDES] Achieving UDI Compliance – More Than Just a Label Change[INFOGRAPHIC] The FDAs UDI Initiative – A Definitive Guide Label Compliance Challenges for Small and Medium Sized Medical Device Companies Label Compliance Challenges for Small and Medium Sized Medical Device Companies Filling the Gap - How Digital Transformation should be embraced when Building your Next-Generation Labeling System Filling the Gap Local Language Labeling Delivered on a Global Scale Local Language Labeling Delivered on a Global Scale A Best Practice Guide to Clinical Trials Labeling A Best Practice Guide to Clinical Trials Labeling Keeping Your Labeling System Ahead of the Curve Keeping Your Labeling System Ahead of the Curve How The GUDID Was it? Implementing and achieving UDI compliance Future-Proofing your Clinical Trial Supply Chain FutureProofing your Clinical Trial Supply Chain for Labeling Mind the Gap! Labeling Experts share the 7 Steps of building a Global Labeling System and reducing the Validation effort Mind the Gap Labeling Experts share the 7 Steps of building a Global Labeling System Bridging the Gap – How to be EU MDR Labeling Compliance Ready by Using the Lessons Learnt from UDI Bridging the Gap – How to be EU MDR Labeling Compliance Ready by Using the Lessons Learnt from UDI

Our Clients

Empowering our Clients to Implement World Class Global Labeling Lifecycle Management Solutions PRISYM ID is proud of its successful working relationships with a diverse spectrum of market leading companies in a wide range of industries including Medical Devices, Pharmaceutical, Healthcare, Clinical Trials, Automotive and Chemicals. We value each customer relationship and pride ourselves on developing long term business ties to maximize the service levels that we can deliver to our clients. Click below to read some of our client case studies:    

About Us

Who are we? PRISYM ID designs and delivers labeling solutions for organizations that need complete product auto-identification and lifecycle traceability. With the continual tightening of labeling regulations and audits, PRISYM ID empowers its clients to safeguard their reputation by ensuring compliance, and significantly reduce costs by eliminating recalls through labeling errors. PRISYM ID is the market leader in world-class label lifecycle management solutions, and is trusted for delivering personalized service excellence to clients in varied sectors including medical device, life sciences, healthcare, automotive, chemical and manufacturing. What do we do? Labeling is an integral component within the manufacturing production process; ensuring products are correctly identified and branded is key. We enable our customers to centrally manage and document the lifecycle of their labels by delivering the ability to securely design, review, approve, print, inspect, reprint and reconcile labels to meet specific validation and compliance requirements. Why choose us? No other solution provider can match the quality of our products, experience and services. We can prove our product excellence and companywide professionalism through six simple proof points… Proof of Precedence Proof of Validation Proof of Compliance Proof of Integration Proof of Delivery Proof of ROI