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INDUSTRY CHALLENGES ANSWERED

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"

LATEST RESOURCES

Medical Device How to Identify, Address and Remove the Risks of Labeling Product Recalls Medical Device: How to Identify, Address and Remove the Risks of Labeling Product Recalls Posted in: Achieving Regulatory Compliance, Business Analysis, Medical Device, Regulatory & Compliance, Webinar -

Join medical device labeling and data experts from PRISYM ID and Reed Tech to find out the latest recalls trends from the industry, to see how the right software platforms can minimize the risks of labeling recalls.

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