Validation Edge, LLC is experienced in developing and executing IQ, OQ and PQ protocols for validating computer systems.
We prepare User Requirement Specifications (URS),Functional Requirement Specifications (FRS), Traceability Matrices, and Protocol Reports to validate our clients' systems.
We always ensure compliance with 21 CFR Part 11 regulations for our clients in Pharmaceutical, Biotechnology, Medical Device, Diagnostic and Active Pharmaceutical Ingredients (API) industry.
- Validation Master Plans
- Risk Assessment Plans
- Validation SOP's
- Vendor Qualification Programs