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.
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"
Whether you’re producing medical devices within Europe or supplying to Europe, as a manufacturer or supplier, you will need to adhere to the new EU MDR.