GAMP 5 - Good Automated Manufacturing Practice
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 6.2.10: Reporting and Release

What does 6.2.10 require?

When the project ends, a computerized system validation report is written that sums up the work done, departures from the plan and actions still open or taken to correct problems, and that gives a verdict on whether the system is fit for the use intended. For some systems, simple or low-risk ones for example, planning may have concluded that no separate report is needed. Putting the system into the operating environment follows a documented, controlled process, as Appendix M7 and section 4.2.4 describe.

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 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

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