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Validation Master Plan

Computers are widely used during development and manufacturing of drugs and medical devices. Correct functioning and performance of software and computer systems play a major role in obtaining consistency, reliability and accuracy of data. Therefore, Computer System Validation (CSV) should be part of any good development and manufacturing practice. It is also requested by the FDA and other regulations and guidelines through the overall requirement that "equipment must be suitable for its intended use". Because of the complexity and long duration of validation activities they should be thoroughly planned, implemented and documented. This master plan and the templates in the attachments should be used as a framework for such planning.

Validation Master Plan - File