Corrective Action Plan

Software Solutions for Corrective Action and Preventive Assure Compliance with 21 CFR Part 11

A Corrective Action Plan is essential in a CAPA system that meets all CAPA requirements as outlined in the 21 CFR 820.100 and 21 CFR 211.180 regulations and in ISO 8402. A corrective action plan is a strategy for correcting or eliminating a nonconformance that has occurred (as opposed to preventing a nonconformance from occurring in the future).

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Importance of CAPA

An effective corrective action plan requires a high level of accuracy and flexibility. Rigorous regulatory requirements exist in the life science and other regulatory industries. Implementing a corrective preventive action plan is part of a requirement of an effective system for corrective action /preventive action (CAPA).

The consistent and proper use of a CAPA systemâ€”including a corrective action planâ€”is the cornerstone of a company's cost reduction and process improvement efforts. The failure to implement a proper CAPA system (which includes a corrective action plan) will likely lead to regulatory action.

MasterControl CAPA automates corrective preventive action to ensure compliance

MasterControl CAPA includes forms for implementing a corrective action plan, and is designed specifically to automate the processes for a corrective action. MasterControl CAPA is an integral component of the MasterControl quality management suite. The software was the first software to enable FDA-regulated industries to comply with 21 CFR Part 11 and meet FDA GMP, GLP and GCP requirements.

MasterControl CAPA (which includes a corrective action plan) is a configurable, off-the-shelf solution that can be quickly installed and implemented, as well as validated.

Hundreds of Companies Worldwide Use MasterControl

MasterControl Inc. software solutions and professional services staff have helped over 200 FDA-regulated manufacturers around the world automate quality systems that comply with 21 CFR Part 11. Our quality management software eases regulatory burdens by helping companies understand and simplify Part 11 and other compliance requirements.

For More Information

For more information about our corrective action plan (which is part of our CAPA solution), please feel free to contact a MasterControl representative.