Posts Tagged 'Csa'

Preparing for the GAMP Transition to Computer Software Assurance

November 10, 2022

Good Automated Manufacturing Practice (GAMP) is, inter alia, a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. GAMP is part of the medical industry’s risk management approach in software development and supports software testing and validation. We thought it would be useful to highlight where GAMP is going as part of the latest guidelines from the Food and Drug Administration (FDA), and how SpiraPlan can help you get there.

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