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 4.2.4: 4.2.4 Reporting and Release

When the project closes, a computerized system validation report sums up the activities performed, deviations from the plan, outstanding and corrective actions and the status of the system, and it gives a verdict on whether the system is fit for the use intended; it mirrors the plan and is approved, as a minimum, by the quality unit and the process owner. Release of the system into the operational environment follows a controlled and documented process, with the project team's handover to the process and system owners and the support organization managed, and the point from which operational change and configuration management applies clearly defined.

Maintained by Gerard BlokdykControl text last updated

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ISO 13485:2016 · 1 control

  • 7.3.7 Design and development validation

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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