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 4.3.1: Operation: Handover

What does 4.3.1 require?

Handover moves the system from the project phase to operational use and transfers responsibility for maintaining the validated state and data integrity to the owners of the process, the data and the system. It is planned, confirms the validated state and business readiness, transfers open items in a controlled way with owners, completes data migration, updates the configuration items and inventory, establishes support agreements and operational procedures, transfers knowledge including implicit knowledge, and may include a defined hypercare period and a rollback strategy, as detailed in Appendix O1.

Maintained by Gerard BlokdykControl text last updated

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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.

ISO 13485:2016 · 1 control

  • 7.3.8 Design and development transfer

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

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