LABELING IS CHALLENGING
New regulations, a global economy and changing
requirements play significant roles.
Let us help you
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.
"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"
Are your current packaging and labeling processes preventing you from creating a faster, more flexible supply chain?
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Companies’ continued reliance on manual processes and disparate labeling systems often culminates in pricey product recalls.