Validation Documentation

Validation Documentation. The collection of all documentation demonstrating that Product equivalence and all applicable regulatory requirements, and any other requirements agreed by the Parties, have been achieved with respect to a proposed new Facility, including master validation plans, qualification documentation (including operational qualification documentation), performance qualification documentation (including protocols and reports), line validation/product performance qualification protocols and reports, and... process failure modes and effects analysis documentation. This information is intended to be delivered as a package and considered for approval as such View More