Key Considerations When Evaluating CAPA Systems

Frequently, we receive questions relating to CAPA (Corrective Action/Preventative Action) and associated closed loop management processes and systems. Since this has been such a popular topic I put together the following recommendations.

Anticipating future issues saves precious time and resources. Ultimately, time spent on avoiding future issues is less costly than correcting them after they happen. This preventative action trending is therefore a good return on investment.

So why does the industry still use tools like spreadsheets, databases and paper-based systems to track their issues and corrective efforts? Reasons include cost, flexibility and sometimes just not knowing what to look for and what is available. A closed-loop corrective and preventative action system (CAPA) is the widely-used and effective process for ensuring safety and quality management. CAPA management ensures that quality control issues can be addressed quickly to make certain these issues do not reoccur.

What do companies need in a CAPA management system? What do you look for in a CAPA system?

1) Cost is always important. If you have a small company, consider a system that does not have a huge startup cost but can also grow as your company grows.

2) Ensure that the CAPA application meets regulatory standards to your industry.

3) Ensure that the CAPA application is role based. At minimum, the roles should include Individual CAPA users, a CAPA Coordinator and Quality Assurance.

4) The CAPA application should have a workflow that ensures the appropriate review occurs at the correct phase of the CAPA development.

5) For larger issues, there may be multiple tasks and multiple people required to correct the issue. The application should be capable of tracking multiple tasks for each issue.

6) There should be an easy reporting system to track the progress of the corrective action to ensure everything finishes on time (Ideally, individuals would be sent emails to notify when tasks are due and when they are running late.

7) Multiple people should be able to access the system simultaneously.

8) For regulated environments, the system should have an audit trail for tracking the history of changes made to the data within the application.

9) The CAPA application should have a means to periodically challenge the corrective action to ensure the correction fixed the initial problem.

Nice to have items include the following:

1) Web based application that does not require the application to be installed and maintained on each workstation. This allows the user to login securely from any workstation with the proper credentials.

2) If the Vendor offers a Validation Package for regulated environments this can greatly reduce the time and cost of validating the package.

Have any comments?  Let me know!