What is GAMP5?
GAMP5 provides a framework for the risk-based approach to computer system validation where a system is evaluated and assigned to a predefined category based on its intended use and complexity. When categorizing systems, it helps with the writing of system documentation.
Why is it important?
- It provides an extensive approach to computer system validation, generally accepted within the industry
- It is in line with the application of the European EMA and US FDA regulations governing computer system validation, Annex 11 and 21 CFR Part 11
- With GAMP5 testing can be tailored to the system being validated, thus making the validation effort more efficient while still demonstrating that the system works as intended.