GAMP 5 - Good Automated Manufacturing Practice
Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 4.4: Retirement Phase: Withdrawal, Decommissioning and Disposal

What does 4.4 require?

Retirement is a formally defined phase of the life cycle, in three activities: withdrawal removes the system from active operation, deactivating normal users and disabling interfaces so no new data is added while special access is retained for reporting and support; decommissioning is the controlled shutdown of the withdrawn system, which may be stored for later reactivation; and disposal permanently destroys data, documentation, software or hardware, with data and documentation destroyed only when their retention period has ended. Retirement is planned, risk-assessed and executed under change control with data migrated, archived or destroyed as decided, and reported, as detailed in Appendix M10.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.