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.
Process audit
Definition of the term (“What is a process audit?”) The term process audit describes the evaluation of the quality capability for products, product groups and