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Corrective Action and Preventive Action / CAPA are required quality measures that must be maintained as outlined in the 21 CFR 820.100 and 21 CFR 211.180 regulations and in ISO 8402. The purpose of CAPA is to make sure the root cause of any problem is addressed so that current or future problems will be alleviated. As witnessed from FDA Form 483 observations and warning letters published on the FDA's Website, corrective action and preventive action problems are dealt with strictly during FDA systems-based inspections. According to the FDA, 30 percent to 50 percent of all 483s are directly due to CAPA nonconformances. These percentages have varied when using different inspection methods by FDA inspectors such as the Quality Systems Inspection Technique / QSIT.
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Controlling documentation is critical to compliance for FDA and ISO-regulated manufacturers. To ensure compliance, companies must control documents so that product is being built off the most current specs. They must also automate manual systems for document control, approval, signoff and change control management processes to improve efficiency. MasterControl provides more than just a docment control system through its integrated quality management software suite that consists of full-featured, integrated modules for change control, CAPA, training, etc. The suite helps ensure compliance with ISO 9000 / ISO 14000 quality standards and FDA regulatory requirements like CGxP, 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 820, 21 CFR Part 606, and Sarbanes-Oxley.
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MasterControl has a variety of industry white papers to help you with your educational and research needs. Click on each white paper for a summary.
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One of the great challenges for Sarbanes-Oxley (SOX) compliance is maintaining the initial compliance. Not only does it mean continuous monitoring, but it also means constant re-assessment of risks and controls. This document change control aspect for both Sections 302 and 404 of SOX is what MasterControl has been supplying to its users for over 10 years through its proven document control system and quality management software.
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