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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, PRISYM 360,  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.

Browse through the challenges wheel below and find out how we can help you with specific challenges.

"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

PRISYM ID Annex VI Infographic Are you Ready for The Annex VI EU No 536/2014 Labeling Changes? Posted in: Achieving Regulatory Compliance, Clinical Trials, Infographic Archives, Regulatory & Compliance -

Changing regulations, such as Annex VI clinical trial regulation, need to be incorporated into the label and artwork processes in time for when the regulation takes effect.

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