Corrective & Preventive Action (CAPA)

Our Industry’s CAPA Dilemma

Year after year, data from the FDA/CDRH Office of Compliance shows that the CAPA subsystem is the most significant source of quality system violations noted by FDA:

  • In 2015 device quality system FDA-483’s, more Observations (384) were lodged against deficient CAPA procedures than any other subsection of 21 CFR 820.
  • Similarly, in 2015 device quality system Warning Letters, CAPA (sec. 820.100) deficiencies made up the largest subset (171/690 or 25%) of citations compared to other 21 CFR 820 sections.
  • From 2003 to 2007, more than 85% of device quality system Warning Letters cited aspects of the CAPA subsystem (820.100 + 820.198 + 820.90). This has increased to a whopping 92% as of 2015, and is higher than any of the four other major subsystems of 21 CFR 820.

During audits and remediation efforts, ComplianceAcuity has observed that CAPA systems are typically laden with misplaced data. This is caused by the lack of an effective mechanism for systematically deciding what problems require CAPA, and what problems don’t.

When used properly, CAPA is a powerful process that can improve your business. But when the wrong data are misdirected into the CAPA system, it overtaxes resources already stressed to begin with. This causes system breakdowns.

The ComplianceAcuity CAPA Solution

At ComplianceAcuity, CAPA is one of our greatest passions. Effective CAPA reduces the cost of quality and streamlines your business. Some of the cornerstones of a ComplianceAcuity CAPA system are:

  • No more arbitrary escalation decisions. We offer a complete and integrated process for systematic data measurement, analysis, and improvement actions addressing data from all parts of the quality system.
  • Risk-based investigation and improvement actions commensurate with the magnitude of the problem. This optimizes resource allocation and reduces waste.
  • Less recurrent problems. Less duplicated efforts. Our system uses strategically-deployed failure investigation to efficiently find the real root cause of defects so that they go away for good.
  • Seamless integration with Risk Management.


“The systems you delivered are highly customized to meet our compliance requirements and business needs.  All interactions were very professional and goal-oriented… Having your regulatory expertise combined with the documentation skills added immense value since we were trying to run the current system while creating a new one.”

  • A 12-year veteran in various positions including Director of Quality
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Our Company Ridgway, CO 81432, USA