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Verification of Effectiveness (VoE) and Verification of Effectiveness Plan (VoEP)

Glossary

Clause 10 Improvement of ISO 9001:2015 and Clause 8.5 Improvement of ISO 13485:2016 state that the corrective actions should be reviewed by the effectiveness after implementation.

 

In addition to the requirements of ISO standards, Clause 3.2.2 of ICH guideline Q10 states that “CAPA should be used and the effectiveness of the actions should be evaluated.”

To sum up, effectiveness checks should be performed after planned actions are in place and verify that the actions have eliminated the underlying root cause.

 

The Verification of Effectiveness Plan (VoEP) is the planning step of the Verification of Effectiveness (VoE) process. VoEP means you need to establish the criteria to verify that the CAPA was indeed effective. When you determine the criteria and get approval, you should verify and document its effectiveness according to it (VoE). If the actions meet the defined criteria, it means that you verified the effectiveness, CAPA can be closed effectively.

 

You can make use of some useful tools that can help you to establish the criteria of your Verification of Effectiveness Plan (VoEP).

Read more: How and why you should review your CAPA process

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