Corrective and Preventive Action (CAPA) Management Services

 

We deliver end-to-end Corrective and Preventive Action (CAPA) management services customized for the medical device industry. Our solutions enable organizations to identify, investigate, and resolve quality issues while proactively preventing their recurrence.

With strong expertise in Regulatory compliance and industry best practices, we assist your team with:

  • Root cause analysis and risk assessment
  • CAPA planning, implementation, and effectiveness verification
  • Documentation aligned with FDA and ISO standards
  • Integration with your QMS for streamlined quality oversight

Our services support organizations in addressing quality concerns, preventing repeat issues, and maintaining compliance with global Regulatory standards such as FDA 21 CFR Part 820 and ISO 13485.

What is CAPA?

Corrective and Preventive Action (CAPA) is a systematic approach used to investigate and resolve quality issues while identifying their root causes. It was introduced in response to requirements set by the Food and Drug Administration under FDA 21 CFR 820.100. CAPA mainly consists of two core functions:

  • Corrective Action
  • Preventive Action

CAPA and the Procedures

Corrective Action aims to identify the root cause of product and quality issues and implement appropriate solutions. This process includes:

  • Review and definition of the problem
  • Identification of the root cause
  • Development of corrective and preventive action plans
  • Implementation of the plan
  • Evaluation of plan effectiveness

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