Annex 11 of EU GMP guideline. It describes requirements for all kinds of computerized systems used as part of GMP-regulated activities.
A computer-based system is a combination of software and hardware components which together fulfill certain functions. The application should be validated, the IT infrastructure should be qualified.
Validation
Definition of the term (“What does validation mean?”) Validation plays a special role in all regulations of the GxP environment. Fundamentally, the validation means providing