Annex 11 to the good manufacturing practices guide: Computerized Systems: GUI-0050

This annex applies to all forms of computerized systems used as part of Good Manufacturing Practices (GMP) regulated activities. A computerized system is a set of software and hardware components which together fulfil certain functionalities.

Data and Resources

Additional Info

Field Value
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward