Automate the GAMP 5 process. Reduce audit times and findings, and decrease the risk of product recalls. Improve product quality and safety. Increase customer satisfaction and ensure regulatory compliance. QMS software makes it all possible.
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In 1991, a group of pharmaceutical experts in the UK started GAMP. They wanted to meet the changing expectations of the FDA for GMP compliance of manufacturing and related systems. Now they are a global organization. GAMP 5 provides “pragmatic guidance, approaches, and tools for the practitioner.” This helps companies find the best approach for validating GxP computerized systems.
GAMP 4 was released in 2001. For seven years, GAMP 4 was used for computerized system validation. Over time, regulatory bodies made significant changes to their approach to regulatory compliance. With those changes, GAMP 5 became necessary. GAMP 5 is designed to be compatible with numerous international standards.
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