GAMP 5 - Good Automated Manufacturing Practice M10: Appendix M10 System Retirement

System retirement is planned as a formal life cycle phase in three activities: retirement removes the system from active operation with normal users deactivated, interfaces disabled and no new data added while special access is retained; decommissioning is the controlled shutdown with storage where reactivation might be needed; and disposal permanently destroys data, documentation, software or hardware, with data and documentation destroyed only after the retention period. A retirement plan draws on the process owner, the system owner, IT and the quality unit, informed by a risk assessment of retiring versus continuing to operate, retention and destruction requirements, the current configuration and interfaces, dependent systems and cloud provider constraints, and is approved by the owners of the process, system and data, the quality unit, and others such as legal as needed. The plan covers roles including a responsible retirement owner and the data owner, overview and implications for strategy including retention of software, licences and hardware for archive access, process, technology scope, boundaries and primary record location, and personnel, the pre- and post-retirement business process, the retirement approach including replacement decisions, decoupling and support transition, data migration, archiving and destruction with data backed up per schedules, retrieval tested before the move, cloud contracts enabling migration or controlled archive, media stored per manufacturer conditions, migration planned, tested and verified and migration tools assessed, verification documentation, discontinuance of support agreements, backup, disaster recovery, security, service levels, cloud subscriptions and inventory entries, formal change management including role changes and stakeholder communication, a schedule with purge periods aligned to retention, execution with cutover, continuity plans and a back-out plan, and the retention of system records, source code and life cycle documentation under a designated data owner in a secure location; a retirement report then summarizes execution, verification results, deviations and where documentation is archived.