CSV– CSA – GAMP – DI

Key Changes in GAMP 5 2nd Edition

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Conclusion: The release of GAMP 5 2nd edition marks a significant advancement in automated systems validation for the pharmaceutical and medical device industries. By enhancing quality risk management, aligning with global standards, embracing agile development, and encouraging innovative technologies, the updated guideline equips organizations with an even more comprehensive approach to automated systems validation. These […]

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CSV– CSA – GAMP – DI

What Does This Mean For The Industry (CSA)

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Topic: Computer Software Assurance Computer Software Assurance (CSA) is a current quality initiative introducing a paradigm shift to enable more streamlined implementation of new technology by removing some computer system validation (CSV) barriers.  Interestingly, this reminds me of March 1997 when the FDA finalized 21 CFR Part 11, the regulations for Electronic Records and Electronic

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CSV– CSA – GAMP – DI

Documentation & Records (CSA)

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Topic: Computer Software Assurance When establishing the record, the manufacturer should capture sufficient objective evidence to demonstrate that the software feature, function, or operation was assessed and performs as intended. In general, the record should include the following: The intended use of the software feature, function, or operation; The determination of risk of the software

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CSV– CSA – GAMP – DI
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