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Writing & Executing a Software Validation Protocol: Plain and Simple
This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results.
While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims , experienced folks will likely find nuggets to help improve their efforts.
Forum: VALIDATION DOCUMENTATION
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How do you create your MVP, who reviews it, who owns it?
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FAT’s and SAT’s what is the difference between both of them. What details do you put in yours?
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This section has being created to discuss best practices for creating URS documents.
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Functional design specifications and how to create a successful one that meets all of the URS requirements.
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How do you set up your RTM documents, how long does it take you to create one from scratch? What do you trace in your RTM?
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What type of checks do you include in your IQ
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What type of checks do you include in your OQ
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What type of checks do you include in your PQ
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How do you record your deviations and discrepancies and how do you close them out?
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How detailed is your summary report, what details do you include in it?
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