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Over a five-year period, PRISYM ID has worked in collaboration with the industry’s leading medical device and pharmaceutical companies to develop a solution that addresses the specific challenges organizations face in these highly regulated markets.

Together, we sought to answer what companies want from a “perfect piece of software” relative to enterprise labeling, active data and FDA and EU requirements, as well as today’s demands including FDA 21 CFR PART 1, Reg 810/820, Unique Device Identification (UDI), Medical Device Regulation (MDR), and many other regulatory requirements. The result has brought together our industry knowledge, experience and client intelligence to create a core solution that is both highly configurable and addresses the short-term and long-term challenges of the industry, as well as full lifecycle documentation based on the GAMP 5 Model for cGMP compliance.

Available as On Premise, Private Cloud or SaaS, our solutions leverage existing network and IT assets, thus reducing capital outlay and protecting prior infrastructure investment.

"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"


Biotec webinar - Are you ready for the Annex VI EU No 536/2014 labeling changes? Are you ready for the Annex VI EU No 536/2014 labeling changes? Posted in: Business Analysis, Clinical Trials, Increasing The Operational Efficiency, Information Technology, Operations & Labeling, Overcoming The Technical Challenges, Project Managers, Supply Chain, Webinar -

Are your current packaging and labeling processes preventing you from creating a faster, more flexible supply chain?

Are you struggling to implement an on-demand packaging model...

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PRISYM ID Recalls E-book How to Avoid Four Common Labeling Product Recalls Posted in: Achieving Regulatory Compliance, Increasing The Operational Efficiency, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Whitepaper -

Companies’ continued reliance on manual processes and disparate labeling systems often culminates in pricey product recalls.

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