PRISYM SaaS enables organizations to address the challenges of complying with FDA UDI, EU MDR and other regulations by delivering access to a compliance ready platform in the Cloud.
With PRISYM 360 technology at its core, PRISYM SaaS provides secure and controlled label design, data management and production printing, offering medical device manufacturers and other life sciences organizations a route to end-to-end label lifecycle management through a scalable cloud-based deployment architecture.
All PRISYM SaaS customer environments are formally qualified using a pre-approved IQ process, and the underlying infrastructure and installed software are formally tested in the Cloud environment. This means a minimum amount of customer specific validation is required to achieve full compliance. By removing most of the validation burden from the customer, PRISYM SaaS allows for rapid and cost- effective deployment in compliance with regulations such as EU MDR or FDA 21 CFR Part 11.
PRISYM SaaS allows you to join the PRISYM Lifetime Partnership Program at a tier suiting your current requirements, enabling seamless upgrade to the next tier as your needs become more complex.
Take our short health check which will provide feedback to help you identify the FDA requirements for the areas where you should spend more time revising your current labeling strategies.