CAPA Programs

Automating CAPA Programs in FDA and ISO Compliance Environments

Recent reports show that 88 percent of FDA warning letters have been issued due to the failure of the CAPA program that a company has implemented. Corrective action software can help companies avoid the failure of a corrective action program.

Corrective Action Preventive Action programs are especially designed to maximize efforts dedicated to the investigation and correction of quality issues in order to prevent recurrence. It is a regulatory requirement that both FDA inspectors and ISO auditors consider singularly critical. When implemented properly, a sound corrective action program improves product quality and safety, increases customer satisfaction, and more importantly, ensures FDA and ISO compliance.

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Data Sheet: MasterControl CAPA
Industry Brief: The 4 Phases of CAPA Maturity: A Guide to Mastering Quality Event Management Industry Brief: Simplify CAPA in 7 Steps

Nonconformance Solutions vs. CAPA Management Solutions

For companies under the jurisdiction of regulatory agencies such as the FDA, EMA, MHRA, MHLW, or those that adhere to ISO, ICH, EU Annex 11 and other international quality standards, any action (or result of an action) that does not meet specified requirements is considered a nonconformance. When a nonconformance occurs, it must be controlled. But depending on its severity, it may not require a CAPA. When a nonconformance does require a corrective action, it may not necessarily call for a preventive action. But serious nonconformances are likely to require both. It is, therefore, important to distinguish nonconformance solutions from CAPA solutions.

For regulated companies, the key is to remember that a corrective action deals with finding the root cause, and effective corrective action solutions must address the cause of nonconformance.

On the other hand, a preventive action, as its name suggests, tries to prevent the problem by determining its likelihood of occurring again and reducing the probability of its recurrence. This essential difference between corrective action and preventive action requires appropriate CAPA solutions that provide appropriate tools.

How MasterControl CAPA Management Solutions Can Help Regulated Companies

MasterControl CAPA solutions are designed to comply with the most stringent regulations anywhere. MasterControl automates and streamlines not only the CAPA process but also nonconformance and other quality processes critical to effective CAPA implementation. MasterControl corrective action solutions provide the following:

Best-Practice Process and Forms: Based on industry best practices, MasterControl's electronic "8D" process will guide the quality team throughout the CAPA process, from root-cause investigation through implementation of preventive action. As part of its CAPA solutions, MasterControl offers a form that will simplify data gathering and can be used as is or configured according to a company's needs.
Part 11 Compliant Features: There are many CAPA solutions available in the market, but with MasterControl, you can rest assured that your CAPA system is compliant with 21 CFR Part 11 requirements on security features, time-stamped audit trail, electronic signature capabilities, etc.
Analytics and Reporting Capabilities: One of the reasons companies look for corrective action solutions is to improve management and monitoring of CAPAs. MasterControl's robust analytics and reporting capabilities provide standard and configurable reports that make the CAPA process more transparent and easier to manage. Reports can be scheduled in advance or sent to users regularly.

MasterControl CAPA Program and Solutions Offer Other Benefits

MasterControl corrective action solutions offer other benefits beyond CAPA management that will help improve your overall compliance efforts, including:

Automation and Streamlining of CAPA and Other Processes: The system automates all CAPA-related documents and tasks, including routing, follow-up, escalation, and approval. It can do the same for all other quality processes critical to compliance. Automation will streamline the process, improving user efficiency.
Integration of Processes, Integration with Other Systems: With MasterControl, you will get more than just CAPA solutions. The system can integrate the CAPA process with nonconformance, document management, training control, audit management, and other quality processes for a more holistic compliance approach. MasterControl corrective action solutions can integrate with existing document repositories and enterprise applications.
Centralized Web-Based Platform: MasterControl's CAPA solutions not only manage the CAPA process, but also provide a centralized web-based platform for all CAPA and other quality related processes and documents. Users will find everything they need pertaining to CAPA and quality compliance in one place. Validation Services: In addition to CAPA solutions, MasterControl offers full, front-to-back validation services and solutions - from planning to protocol creation and definition of the project, systems configuration, risk management through customized validation testing and reporting.