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.
All guidelines for good working practice, which are particularly important in medicine, pharmacy and pharmaceutical chemistry, are summarised by the abbreviation GxP. The “G” stands for