System Qualification
From WikiBioPharm
System Validation is a broad term meaning the validation of a group components which working in conjunction, with a defined operational function.
Two common system subgroups are utility systems and computer systems. Utility systems may include, but are not limited to, HVAC systems, Water for Injection (WFI) systems, purified water systems, clean steam systems, and gas supply systems. Utility System Validation includes some general requirements seen in all validation of Utility Systems as well as some system specific testing. Computer System Validation (CSV) has become a major part of the validation sub-industry as a result of the life-sciences industries moving more toward keeping electronic records and using computers to create more effecient processes.
Validation of other common utility systems include:
- HVAC System Validation
- Water for Injection System Validation
- Purified Water System Validation
- Gas System Validation
- Plant Steam Validation
- Clean Steam System Validation
General other systems:
