Corrective Action - Preventive Action (CAPA)


GMP deviations anywhere in your company should feed right into a well-functioning written CAPA process.

Whether it's customer complaints, specification failures, vendor issues, or inspection observations, you need a clear and practical way to identify, investigate, and resolve them all.

We can help your company build a more effective CAPA process. It will be clear, it will be documented, and every employee in your operation will understand how it works and what their CAPA roles and responsibilities are.

FDA inspectors are trained to ask, "So...when you discover a problem in this area, what happens next?" With the follow-up, "Could you show me your documentation files on that."

FDA inspectors know that a healthy CAPA process is a key indicator of a true GMP environment in any company. So putting some extra effort into CAPA is a good investment.

Our CAPA experience will help you save a lot of time and money. We encourage you to give us a call.