CAPA programs

Corrective Actions and Preventative Actions, or CAPA programs are an integral element in every quality management system. Implementing a CAPA program within iPassport QMS helps your laboratory improve compliance through improved documentation and follow up on all CAPAs generated.

Implementing a CAPA program within your institution begins with identification of the issue, whether there is an incident in the laboratory or elsewhere. iPassport allows you to document the identification of the issue through incident reports as well as providing the ability to upload scanned forms documenting the identification event, the first step in the action plan within your CAPA program.

The next step in the CAPA program is evaluation of the problem. Documenting your evaluation, whether it be a discussion held within meeting minutes on the iPassport system or by scanning attached evaluation information to the incident itself, your compliance efforts are improved through improved documentation thereby increasing the efficiency of your CAPA program.

Investigation of the problem is the next step in the CAPA program action process. Investigation information can be held within the iPassport QMS system so that incident documentation is complete with a permanent, searchable record held directly on your laboratories quality management system. Permissions can be restricted so that only certain users can view the information; alternatively the information can be shared so that each member of staff benefits from the knowledge gained from the CAPA process.

A quality CAPA program also entails a detailed analysis of the issue in order to implement a corrective action plan. Your action plan is a detailed plan which takes the information you’ve gained from previous steps in the CAPA program and utilizes them to gain an informed perspective to put plans in place for the next step of the action process, the Implementation stage. The implementation phase can be completely tracked on the iPassport system, for example procedure revisions or policy revisions can be documented within iPassport QMS or additionally, the implementation can be tracked within centrally held meeting minutes or changes to health and safety documentation. This in turn allows you to document all steps in your CAPA program, improving compliance while also improving the quality and efficiency in the laboratory.

The final step in the CAPA program action process is the follow up step. A task can be generated from the incident itself within iPassport QMS so that all staff involved with the particular incident can be notified either on the system or via email of the actions required of themselves, whether it be to read an amendment to a policy through to attending a meeting regarding the CAPA program itself. Please visit the iPassport page for more information, or contact us so that you can improve upon your existing CAPA program immediately!

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