Should I Revalidate My Software?｜質量分析計・LC-MS/MSシステムのSCIEX

For research use only. Not for use in diagnostic procedures.

Answer

Periodic reviews of validated systems must be performed to ensure that no changes have been made that affect the validated state of the system. If there is a change, then the software needs to be revalidated. The change must be managed via a written change control procedure, which includes a documented risk assessment and appropriate testing.