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.
Enterprise Content Management System (ECM)
Definition of the term (“What is ECM?”) ECM is the abbreviation of Enterprise Content Management. This is the management of all data and information generated in