CAPA Plans

Plans that are developed and implemented to identify, remediate, and prevent recurrence or occurrence of existing or potential causes of non-compliance or other quality issues.  RQA assists investigators and their research teams in the develpement of CAPA Plans.  

We provide assistance with the following CAPA Plans:

Internal Quality Reviews

Following each internal review conducted by RQA Auditors, the CAPA Manager provides assistance and guidance to the PI and study team in the creation of a response, also known as a Corrective and Preventive Action (CAPA) Plan that is both specific and measurable.

See link to Creating Internal CAPA Plan Flowchart

Federal Audits 

During an external audit conducted by a federal or other governmental agency, the CAPA Manager works closely with the PI and study team to facilitate and expedite the process of responding to questions or requests from the federal/governmental inspector(s).

At the conclusion of such audit, a CAPA Plan may be requested by federal agencies such as FDA, OHRP, NIH, DOD, EMA. 

The CAPA Manager provides guidance and support on strategies for corrective and/or preventive actions and for CAPA Plan formulation and implementation. 

As outlined in Policy HSR-P-004: Corrective Action Preventive Action (CAPA) Plan, CAPA Plans requested by a federal agency, must be submitted to RQA for review. Once finalized, the CAPA Plan is provided to relevant University leadership for their approval. The final CAPA Plan  is then submitted to the federal agency.

External Audits

The CAPA Manager is available for assistance in the creation of a CAPA Plan at the request of the researcher for audits conducted by external organizations (industry sponsor, contract research organization (CRO).

Full CAPA Plans

When a systemic problem is detected internally, the VPR/IO or others may request that a department, facility or unit create and implement a full CAPA Plan. The CAPA Manager provides training in the creation and implementation of a full CAPA Plan.

See link to Seven Steps to Creating an Effective CAPA Plan.