CAPA Verification of Effectiveness Checks

To ensure that each verification of effectiveness check is complete and appropriate, consider the following:

• The CAPA record should have a section to record a description of the method, when it will be done and who will do it. Failure to record this information up front makes it appear that this activity wasn’t considered.

• Some effectiveness checks may require an extended monitoring period. However, each check should be timely and commensurate with the nature of the CAPA.

• An internal audit may not be the best method, especially if the CAPA is complex or technical in nature and not easily understood by the auditor.

• If the CAPA required validation prior to implementation, ask yourself if an effectiveness check is required. (hint: no). Document your rationale on the CAPA form.