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