Corrective Action (CAPA) Database


Why Regulated Companies Need a CAPA Database

In regulated environments, corrective action and preventive action (CAPA) is a cornerstone of quality. The need for CAPA can be found in regulations (e.g., FDA's 21 CFR 820.100), standards (e.g., ISO 9000, ISO 13485) and guidelines (ICH Good Clinical Practice). For the purpose of compliance and to ensure the safety and quality of products, regulated companies should have a CAPA process and a CAPA database in place.

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CAPA Database vis-á-vis CAPA Process

Some regulated companies do not have a formal CAPA process, but all regulated companies are likely to have quality control and quality assurance processes, both of which utilize CAPA.

For companies without a formal CAPA process, a simple CAPA database may be helpful. Depending on a company's size, the nature of its business, and the regulations and standards it complies with, a corrective action database can be as simple as a spreadsheet or as sophisticated as an electronic system. What is important is that the CAPA database is in accordance with the regulations and standards applicable to the company.

For example, medical device manufacturers that sell their products in the United States must comply with specific CAPA requirements under 21 CFR Part 820.100. The regulation requires manufacturers to collect and analyze data to identify nonconforming products and other quality problems. It requires investigation of the problem's cause and implementation of CAPA. In this context, a medical device manufacturer creating a corrective action database should consider how the database would help not only in collecting and identifying quality problems that could lead to CAPA, but also how it can help in the analysis and investigation of the cause.

Not all nonconformances and deviations require CAPA. The depth of a CAPA investigation and implementation should always be based on risk. For example, the ICH Good Clinical Practice Guidelines list the types of protocol deviations that are considered "serious breaches" and require appropriately serious CAPAs. So, in creating a CAPA database, the regulated company should keep in mind the need to identify CAPAs and categorize them based on the seriousness of the risks they pose.

Establishing an Effective CAPA Database with MasterControl

MasterControl CAPA™is an easy-to-use, easy-to-implement web-based software solution that automates, streamlines, and effectively manages the CAPA process. The solution is designed to integrate the CAPA process with other quality processes such as document management, training control, change control, nonconformance management, and audit management. The solution can serve as framework for a CAPA database and a platform for all CAPA-related documents and records.

For an effective corrective action database, consider the following MasterControl features:

  • Best-Practice Forms: MasterControl provides best-practice forms and workflows, including "8D" process, to guide every step of a CAPA implementation. These CAPA forms can be an essential component of a CAPA database.
  • Analytics and Reporting: MasterControl's advanced analytics and reporting capability provides standard and customized reports. With MasterControl, a CAPA database can include customized reports that summarize CAPA in multiple levels, such as by product, department, and root cause.
  • Part 11-Compliant Features: MasterControl provides time-stamped audit trail, electronic signatures, and reporting capabilities designed to comply with 21 CFR Part 11. For FDA-regulated companies that are establishing a corrective action database, these features are critical.
  • Centralized Repository: MasterControl automates paper-based or hybrid CAPA processes and provides a centralized repository for all CAPA-related information you need to include.

Electronic CAPA Database Offers Additional Benefits

With MasterControl, creating an effective CAPA database is easier and faster. In addition, MasterControl offers the following benefits:

  • Increased Efficiency: Automation of routing, follow-up, escalation, and approval of all CAPA documents and tasks greatly increases efficiency. Having a single location for all CAPA-related tasks also helps save time and effort when searching and tracking documents.
  • Integrated Processes: The CAPA process, including the corrective action database, should be part of a holistic quality management system. With MasterControl, the CAPA process can be integrated with other critical processes such as nonconformance management, training control, change control, audit management, and document management. For companies that use other electronic systems, MasterControl can be integrated with document repositories and enterprise applications like ERP and LIMS without expensive custom coding.
  • Compliant System: In regulated environments, a CAPA database, just like the CAPA process itself, must be compliant. MasterControl helps regulated companies increase inspection readiness and sustain compliance by streamlining and strengthening their quality systems.

For More Information on Corrective Action (CAPA) Database

To learn more about our corrective action program database contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.