What should be done with the observations and findings from an audit?

Boost your GCP E6 (R3) exam readiness. Improve your understanding with engaging, insightful questions. Test yourself with hints and detailed explanations. Prepare effectively!

Multiple Choice

What should be done with the observations and findings from an audit?

Explanation:
Observations from an audit must be documented in a formal audit finding. Documenting captures a clear description of each finding, the applicable standard or procedure, the potential or actual impact, the root cause as identified, and the recommended corrective actions with assigned responsibility and target dates. This creates a traceable record that supports accountability, CAPA, and trend analysis, and provides a basis for follow-up and external review. After the finding is documented, it should be communicated to the appropriate stakeholders and tracked through to closure; ignoring issues is not acceptable, and simply taping or archiving records does not replace written documentation and action.

Observations from an audit must be documented in a formal audit finding. Documenting captures a clear description of each finding, the applicable standard or procedure, the potential or actual impact, the root cause as identified, and the recommended corrective actions with assigned responsibility and target dates. This creates a traceable record that supports accountability, CAPA, and trend analysis, and provides a basis for follow-up and external review. After the finding is documented, it should be communicated to the appropriate stakeholders and tracked through to closure; ignoring issues is not acceptable, and simply taping or archiving records does not replace written documentation and action.

Subscribe

Get the latest from Passetra

You can unsubscribe at any time. Read our privacy policy