CAPA Remediation Plan

The team of experts at Audree Infotech can help organisations identify the root cause of a problem, and then implement a CAPA plan for enabling our clients to comply with regulatory requirements.

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CAPA Remediation:

Corrective and preventive action (CAPA) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is set of actions that laws/regulations require an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring non-performance. Non-conformance identified after systematic evaluation and analysis of the root cause of the non-conformance. Non-conformance may be a market complaint or customer complaint or failure of machinery or a quality management system, or misinterpretation of written instructions to carry out work. A team that includes QA personnel involvement in the actual observation point of non-conformance designs the corrective and preventive action.

Corrective action: Action taken to eliminate the causes of non-conformities or other undesirable situations.

Preventive action: Action taken to prevent further reoccurrence of such non-conformities.

CAPA may be required as part of the quality management system in Medical Devices and Pharmaceutical industries. CAPA is use to bring about improvements to an organization's processes, and is often undertaken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP) and focuses on the systematic investigation of the root causes of identified problems/risks in an attempt to prevent their recurrence or to prevent occurrence.

Corrective actions can implement in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit, as well as adverse or unstable trends in product and process monitoring. Preventive actions can implement in response to the identification of potential sources of non-conformity.

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