Out of specifications Deviation handling procedure Software uses

Question

Accepted Answer

The out of specifications deviation handling procedure involves identifying, documenting, investigating, and resolving any deviations from specifications in software.

Identify the deviation from specifications in the software
Document the deviation with details such as date, time, and nature of the deviation
Investigate the root cause of the deviation
Implement corrective actions to resolve the deviation and prevent recurrence
Review and approve the deviation handling procedure

Accepted Answer

Details given FDA guidelines and MHRA Guidelines 
Deviation process
Software and instrument handled