Label design, validation and lifecycle management for life sciences - developed for FDA compliance
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.
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
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.
- [DATASHEET] PRISYM Medica 1.45 MB
- [WHITEPAPER] How to Ensure FDA Compliance383.15 KB
- [WEBINAR WATCH-BACK] The Compliance Crackdown: Guarding Against FDA Action33.55 MB
- [WHITEPAPER] Implementing UDI (Unique Device Identification) 122.42 KB
- [INFOGRAPHIC] An Insight to Customers Top Labeling Challenges561.5 KB
- [INFOGRAPHIC] The FDAs UDI Initiative – A Definitive Guide804.14 KB