Video

Documenting Protocol Results

During the finale of his presentation at IVT's Validation Week East Coast Update, Joseph Zec analyzed the intricacies of documenting validation protocol results. The regulatory expectation of objective evidence, as per US Food and Drug Administration's General Principles  of Software Validation, is explained. Zec led the audience through handling test deviations, the issue management process and tools, manual issue management pitfalls, and test script annotation.

See more of Joe Zec, three-time IVT Speaker of the Year, at the 5th Annual Validation Week EU

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