Recommendations and Best Practices – GAMP®5
GAMP®5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification.
GAMP® 5 has become the computer system validation ‘bible’ for the pharmaceutical industry. The concepts described in the approach are quite sound and applicable to computer systems validation across the life cycle disciplines.
The Bottom Line
As the title suggests, “A Risk-Based Approach to Compliant GxP Computerized Systems”, the approach is definitely risk-based, which aligns with the “current thinking” by the regulatory bodies. The bottom line is that the life sciences are strictly regulated and there’s a lot of “help” available.
This program will pull the best information from the various sources to help you understand what is required for a compliant computer validation system and the best practices that are required in implementing your system.