Software Development (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 a systems it helps with the writing of system documentation

Why GAMP5 is 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
  • Qith 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.

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