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Paperless Validation in an Agile Environment

‐ May 10, 2023 10:15am

Most customised software is created nowadays using Agile principles. However, validation of software is still used in a waterfall approach using the famous V-model of GAMP. Innovation in validation, as defined in the GAMP Good Practice Guide, "Enabling Innovations", and GAMP 5 2nd edition, shows that an Agile type of validation can bring a lot of improvements for validating GAMP software category systems 4 (configurable) and 5 (customised). This presentation will show a clear example of an Agile validation approach using tools resulting in a solid, but flexible validation, where paper is no longer required. A tool takes care of full traceability throughout the whole life cycle of the system.


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