A corrective action preventive action plan is essential to any company that is expected to meet all CAPA requirements as outlined in the 21 CFR 820.100 and 21 CFR 211.180 regulations and in ISO 8402.
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A corrective action plan is a strategy for correcting or eliminating a problem that has already occurred or been identified (as opposed to a preventive action plan which defines the steps taken to eliminate the root cause of a problem to prevent it from recurring ). It is important to establish a corrective action preventive action plan throughout your organization because correcting and preventing SOP problems early will cost significantly less than fixing them later. To learn more about CAPA plans and the steps you can take to establish a successful CAPA plan in your company, please watch or download the information provided below about the benefits of implementing an effective CAPA system.
An effective corrective action preventive action plan requires a high level of accuracy and flexibility. Because of the rigorous regulatory requirements that exist in the life science industries, implementing an efficient CAPA plan sooner rather than later is recommend to avoid regulatory discipline. The consistent use of a comprehensive CAPA system, which includes a corrective action plan, is the cornerstone of a company's cost reduction and process improvement efforts. Organizations who fail to implement and follow effective CAPA plans are often the recipients of CAPA warnings, ISO audits, and FDA investigations.
An automated corrective and preventive action plan system like MasterControl CAPA includes electronic forms for implementing a corrective action plan, and is designed specifically to automate the manual processes regularly used to resolve CAPA issues. By instituting a uniform method for investigating problems, including a solid process for verifying and validating corrective actions, your organization can avoid "death by CAPA" and significantly reduce its open CAPAs.
MasterControl's electronic CAPA plan software is an integral component of the MasterControl quality management system (QMS) suite - the first software of its kind to enable FDA-regulated industries to comply with 21 CFR Part 11 and meet FDA GMP, GLP, and GCP requirements.
Customers like MasterControl CAPA plan software because it's a configurable, off-the-shelf solution that can be installed, implemented, and validated quickly for faster CAPA compliance. Our CAPA solution eases your regulatory burdens by helping you understand and simplify Part 11 and other complex compliance requirements. We've helped regulated manufacturers around the world automate their corrective action and preventive action plans to achieve 21 CFR Part 11 compliance. We can help you, too.
For more information about our corrective action preventive action plan (which is part of our CAPA solution), please feel free to contact a MasterControl representative.