Before GAMP, companies often applied the same rigid, document-heavy validation approach to all systems—from a simple centrifuge to a complex manufacturing execution system (MES). This led to wasted effort, inflated costs, and ironically, overlooked critical risks.
Regulatory bodies like the FDA (21 CFR Part 11) and EU Annex 11 require evidence that computer systems are validated. GAMP provides the roadmap to produce this evidence. what is gamp
GAMP introduced two revolutionary ideas: Before GAMP, companies often applied the same rigid,
In the highly regulated world of pharmaceuticals, biotechnology, and medical devices, data integrity and patient safety are paramount. , which stands for Good Automated Manufacturing Practice , is the industry standard for achieving these goals. GAMP provides the roadmap to produce this evidence
Through their efforts, they discovered that the problem was not with the system itself, but with the way it had been validated. They had not followed the GAMP guidelines closely enough, and as a result, the system had not been properly tested.
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