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PRISYM 360

A Revolution in Label Lifecycle Management - Take a 360° View of Your Label Production Process to Ensure FDA Compliance Overview In PRISYM 360, we have brought together all of our industry knowledge, experience and client intelligence to create an elite core solution that is highly configurable to your company’s requirements and quick to deploy. PRISYM 360 is a powerful, comprehensive, scalable and validatable enterprise labeling solution which offers medical device manufacturers complete label integrity from data management to design and approval through to label production and inspection to meet the strictest compliance requirements including FDA & EU regulations. 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. With PRISYM 360,  the costly mislabeling of medical devices is now avoidable. By providing a revolutionary 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. Download the PRISYM 360 Brochure to Learn More  Features & Benefits By implementing PRISYM 360, your organization will gain the following operational advantages: Provides a single scalable Label Lifecycle Management (LLM) platform across the enterprise that can mitigate the costly risk of product recalls due to labeling errors Supports 3rd party manufacturing, packaging, and labeling operations to assist with operational efficiency objectives Offers UDI readiness to support the FDA’s upcoming compliance requirements Supports local language and country specific labeling operations across the globe Utilizes a global workflow for reviewing, approving, and version controlling label formats and data with high visibility and traceability Lifecycle documentation based on the GAMP 5 Model to gain cGMP compliance by meeting all guidelines  Provides a platform to achieve global standardization of the labeling lifecycle including data, format, brand and operating procedures Implements a harmonized process to control the creation, editing and operational use of labeling content throughout the business Consolidates, controls and captures all instances of production label prints across manufacturing lines, distribution centers, as well as by 3rd party manufacturers Achieves significantly greater flexibility and control when managing production labeling of a specific product in multiple locations Leverages your existing network and IT assets, thus reducing capital outlay and protecting prior infrastructure investment Meets rapid deployment and validation specific requirements through low risk configuration which accelerates operational efficiencies and ROI Download the PRISYM 360 Brochure to Learn More  Expertise PRISYM ID has specialist professionals to support your global Label Lifecycle Management. Proven track record of implementations with global organizations, delivering rapidly realized business benefit and tangible return on investment Demonstrable history of software innovation providing leading edge solutions to clients regulated by the FDA and EU Skilled professional services team to aid with solution design, implementation, configuration and training Skilled validation experts to work with quality teams to support the implementation of a compliant Label Lifecycle Management solution in accordance with corporate quality guidelines In-house development, test and support teams to provide a complete end-to-end solution from a single vendor Global 24/7 software support Accredited as a GS1 solution provider to ensure production of compliant barcodes Download the PRISYM 360 Brochure to Learn More  Blueprints As part of PRISYM 360 we have created six pre-configured and pre-validated print solutions. These standard out-of-the-box print front ends have been designed to provide a solution to common labeling and business process challenges whilst reducing cost and increasing speed of deployment. PRISYM BluePrints include solutions for: 1. Sales Order/Goods Out Process 2. Purchase Order/Goods In Process3. Product Printing Process: for small numbers of easily identifiable products 4. Approved Label Printing Process: for small numbers of labels across many products5. Batch Manufacturing Process6. Works Order Based Process CONTACT OUR TEAM TO FIND OUT MORE >

Vision Inspection Systems

Error-Free Labeling for the Medical Device Market PRISYM VISION  We have developed PRISYM 360 Vision, a module for PRISYM 360 label management software, to provide complete print inspection set up, test and management functionality. It is fully integrated with Crest Solutions’ industry-leading PrintInspector TM, a high accuracy, in-line print verification system. Being the first, fully integrated label software and print inspection solution, it delivers business benefits not available from other technologies:Reduces CostA single, integrated system comprising label management software with print inspection hardware minimizes effort in both inspection setup and operation.Removes RiskAutomated inspection of every label using both the design and the content sent to print.Ensures ComplianceAutomatic logging of print failure details with actual images in a secure audit log ensures regulatory compliance. WHO WOULD BUY IT? Medical Device manufacturers which print labels for medical devices Bio-pharma firms that perform in-house printing of complex, trial-specific labels for clinical studies Contract Manufacturers and Clinical Supplies Organisations which are printing primary and secondary labels for clinical study customers Download the PRISYM Vision Datasheet to Learn More  Features & Benefits PRISYM Vision 360 is the only label management software to be fully integrated with print inspection hardware, reducing costs and removing risk whilst ensuring regulatory compliance. FEATURES BENEFITS Vision Inspection Wizard creates inspection masks automatically from label designs Reduces the effort and expertise necessary for configuration and testing All features available through PRISYM 360 user interface Ease of use minimizes operational costs Performance optimized design minimizes delays in print and inspection Increases operational throughput and efficiency Inspections performed on both label design and specific label content Reduces risk as more errors are detected Inspection results automatically recorded in single, secure electronic audit log Ensures fast, comprehensive and compliant responses to regulatory audit requests    Read Our Whitepaper To Get a Solid Understanding Of Vision Systems   Expertise The PRISYM ID team has specialist knowledge to make sure you know the “do’s and don’ts” of life sciences label design and lifecycle management. "It was pretty obvious from the beginning that PRISYM ID has a very strong grasp on software validation and the implications of FDA 21 CFR Part 11. PRISYM ID has provided us with a labeling backbone integrated to our other enterprise systems and our product database." 30 years' experience in the labeling and auto-identification market, working with a range of companies from start-ups to blue chip organizations Accredited as a GS1 solution provider to make sure our clients produce compliant GS1 barcodes In-house test and validation team to support all compliance requirements and lifecycle documentation Experienced consultancy team to aid you with solution implementation, configuration and training Specialist expert developers building specific printer drivers to ensure high speed data transfer to a wide range of devices 24/7 software support services that will seamlessly manage your company’s needs from troubleshooting to upgrades, re-installation, and configurations.  Read Our Whitepaper For Expert Guidance On Vision Systems   INSPECTION Crest Solutions PrintInspector™; a high accuracy in-line print verification system can be supplied as an add on to your existing labeling production process to remove the need for manual label inspection. The variety of print problems that can occur in the fine detail has hindered the ability for many manufacturers to meet high industry standards of accuracy in the use of labels for medical device packaging. Inspecting for these print problems through human or partially automated systems has been proven to be insufficient, unreliable and creates risk. Implementing PrintInspector™ eliminates this risk. PrintInspector™ is a high resolution (300dpi) scanning system that mounts directly onto standard thermal or laser printers and is specifically designed to address verification problems relating to large format labels of up to A4 in size. Watch Our PrintInspector Video To See How Label Inspection Works  We have developed PRISYM 360 Vision, a module for PRISYM 360 label management software, to provide complete print inspection set up, test and management functionality. It is fully integrated with Crest Solutions’ industry-leading PrintInspector TM, a high accuracy, in-line print verification system. Being the first, fully integrated label software and print inspection solution, it delivers business benefits not available from other technologies: Reduces Cost A single, integrated system comprising label management software with print inspection hardware minimizes effort in both inspection setup and operation. Removes Risk Automated inspection of every label using both the design and the content sent to print. Ensures Compliance Automatic logging of print failure details with actual images in a secure audit log ensures regulatory compliance.   WHO WOULD BUY IT?                 Medical Device manufacturers which print labels for medical devices                 Bio-pharma firms that perform in-house printing of complex, trial-specific labels for clinical studies                 Contract Manufacturers and Clinical Supplies Organisations which are printing primary and secondary labels for clinical study customers

PRISYM Medica

PRISYM Medica

Label design, validation and lifecycle management for life sciences - developed for FDA compliance Overview PRISYM Medica is an enterprise labeling solution for medical device and life sciences organizations, specifically designed to meet international compliance requirements such as the FDA’s labeling guidelines including 21CFR part 11. The web-based medical device labeling software solution allows organizations to generate labels worldwide – from the head office, sub-divisions, and third party suppliers to manufacturing sites - whilst still keeping central control. Using purpose-built user security, group security and secure audit logging, you can design, review, approve, print, reprint and reconcile labels with all labels and supporting documents produced in an auditable manner. PRISYM Medica is supplied as a validated labeling solution including auditable security protocols and lifecycle documentation based on the GAMP 5 Model. The medical device labeling software has been deployed by some of the world’s largest life science companies including medical device, pharmaceutical and clinical trials; companies typified by the need for compliant printing solutions in highly regulated environments. Download the PRISYM Medica Datasheet to Learn More  Features & Benefits PRISYM Medica has positively impacted the streamlining of labeling processes for many of the top medical device companies around the globe. Management of on-demand labeling processes – from manufacturing labels to integrating with existing applications. It offers one complete solution across the business that is inclusive of quality control, engineering, marketing and production Ability to meet global regulations, such as FDA compliance requirements including 21CFR Part 11, Part 820 and UDI readiness Auditable security protocols and lifecycle documentation based on the GAMP 5 Model to gain GMP compliance by meeting all guidelines Proactive review and approval work engine that reduces the likelihood of production errors and product recalls Auditable security protocols to control user permissions including design, review and approval privileges Links to ERP and MRP systems to ensure that all information from production can be delivered to the label at time of print. Over 500 printer drivers within the software, specifically written by our expert developers to ensure high speed data transfer to a wide range of devices including thermal transfer printers, inkjet coders and RFID coders Integration with Vision Inspection solutions for post print compliance Download the PRISYM Medica Datasheet to Learn More  Expertise The PRISYM ID team has specialist knowledge to make sure you know the “do’s and don’ts” of life sciences label design and lifecycle management. "It was pretty obvious from the beginning that PRISYM ID has a very strong grasp on software validation and the implications of FDA 21 CFR Part 11. PRISYM ID has provided us with a labeling backbone integrated to our other enterprise systems and our product database." 30 years' experience in the labeling and auto-identification market, working with a range of companies from start-ups to blue chip organizations Accredited as a GS1 solution provider to make sure our clients produce compliant GS1 barcodes In-house test and validation team to support all compliance requirements and lifecycle documentation Experienced consultancy team to aid you with solution implementation, configuration and training Specialist expert developers building specific printer drivers to ensure high speed data transfer to a wide range of devices 24/7 software support services that will seamlessly manage your company’s needs from troubleshooting to upgrades, re-installation, and configurations. Download the PRISYM Medica Datasheet to Learn More