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Essential Elements of Effective CAPA Systems

Ken Peterson
Tue, 04/22/2008 - 22:00
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From the perspective of the U.S. Food and Drug Administration and other regulatory agencies, corrective and preventive action (CAPA) is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls, material controls, and facility and equipment controls. Because more than half of Form 483 observations and warning letters cite CAPA deficiencies, it’s evident that FDA investigators are likely to look first at a company’s CAPA system during their inspections. In recent years, the FDA has been promoting the adoption of closed-loop CAPA systems where CAPA is the tool that drives reports and keeps management informed.

The objective of CAPA is a solution to the issue from which the CAPA was generated. If it isn’t driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, all control points flow through to the CAPA system.

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Comments

Submitted by ccoles3 on Tue, 03/19/2013 - 06:34

CAPA Systems

We have been using CAPA Manager from Adaptive BMS because its cost effective and works well. For us, the use of a CAPA system has saved us a lot of money as well as dramatically improving our product quality.

It has taken about 12 months for the CAPA culture to really take hold. We are now processing about 11 CAPA's per employee per year (all resulting in some improvement for our business).

A very successful system for us. I don’t think I could run a production and engineering company without a CAPA system in place.

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Submitted by kingtim04 on Tue, 07/28/2015 - 17:37

Verification of CAPA Effectiveness

Ensuring CAPA effectiveness is such a critical point when it comes to eliminating root cause. Other than the common effectiveness criteria of no repeat occurrences over a period of time, what are some other ways to verify your CAPA has been effective?

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