Processes:
- Change Management
- Configuration Management
- Repair Activity
Key requirement is that all changes should be reviewed, impact & risk assessed, authorized, documented, tested and approved before implementation. Each change has to follow the V-model.
Change Management
Change management controls life cycle of changes end enables beneficial changes made without compromising regulated processes with minimum disruption to services.
Configuration Management
Hardware & software configuration must be documented throughout system life.
Repair Activity
Activities to repair or replace failed or defective component are implemented following a defined, approved & verified procedure.