Posts Tagged 'Gamp'

Recap: Embedding GAMP Compliance into Digital Health Software

April 3, 2023

Inflectra launched a new webinar series called "Journey into Risk Management" on March 29, 2023, with the first event hosted by Dr. Sriram Rajagopalan. The webinar, titled "Embedding GAMP Compliance into Digital Health Software," focused on implementing validation testing for Good Automated Manufacturing Practice (GAMP), which is a general automation manufacturing process, often used in e-health software development and validation as a Risk-Based Approach to Compliant GxP Computerized Systems.


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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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