Validation Center™ was created by Praxis Life Sciences afer years of experience working with pharmaceutical, medical device and clinical research companies to build and validate computer systems to meet FDA standards. The templates and information in Validation Center™ are the same templates, samples, SOPs, regulations, etc. that Praxis consultants use on projects and in our training workshops.
Here are just a few of the types of templates included:
- SOP for Computer System Validation
- SOP for Software Development Life Cycle
- Specification templates (User, Functional, and System)
- Test Protocol templates (IQ, OQ, and PQ)
- Testing and Validation Summary Reports
- Deployment Plans
- Vendor audit templates
But Validation Center™ is more than a template library. It also contains copies for FDA 483's and Warning Letters that we has gathered that provide real insight into the types of observations that the FDA makes regarding computer systems. This helps you separate the "truth" about FDA actions from speculation.
Validation Center™ evolves and changes over time. Praxis adds new information regularly. Similarly, we encourage members to bring their ideas, solutions, and challenges into the discussion forums to facilitate knowledge exchange.