Validation Edge, LLC prepares and executes protocols for Commissioning, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to qualify the Facilities, Utilities and Equipment used for the manufacturing and packaging of products in pharmaceutical, biotechnology, medical device, diagnostic and Active Pharmaceutical Ingredients (API) industry. We also prepare final reports for the executed protocols.
We work with our clients for developing User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
We also assist clients with performing Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
Our strength lies in leveraging technical information from vendors' documentation to develop technically sound protocols for reducing the project cost, and enhancing the level of reliability and compliance.