The necessity of GAMP5 2nd Ed. and the FDA’s CSA guidance
Navigating the complex world of computer systems in the regulated life sciences industry can be made simpler by adhering to guidelines such as the ISPE’s Good Automated Manufacturing Practice (©GAMP). The GAMP5 Second Edition, coupled with the FDA’s Draft Guidance on Computer Software Assurance for manufacturing, operations and quality system software, provide a solid basis for risk-focused computer system validation and assurance.
The purpose of combining the GAMP and FDA methods is to ensure regulatory compliance, promote efficiency, consistently deliver high quality and ensure the system is fit for its intended use across all GxP applications. In essence, the GAMP guidelines advocate a realistic, risk-based approach to compliance for automated computer systems used in regulated pharmaceutical research, manufacturing and distribution.
In this white paper:
- Differences between computer system validation and computer software assurance
- GAMP5’s pragmatic principles
- Consequences of overly conservative approaches
- The need for proactive, balanced innovation cultures
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