QC Analytics

Software Development (GAMP5)

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.
The next steps after reaching out to us
  • We both can sign a confidential agreement (if required)
  • We create a customized quote just for you (as soon as possible and with no delays)
  • We provide support based on your needs.