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CAPA Program: Segregation of CA's and PA's
Written by Brian Graeff, Brian Graeff LLC ; Benoit Prince, SOLABS ; Philippe Gaudreau, SOLABS
CAPA is a well-known cGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. CAPA is not just a procedure; it is a system of very different, but interrelated activities.
The acronym "CAPA" is currently used in the regulated industries, but the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action. A good CAPA program should differentiate actions in the following manner:
When a quality event is identified (such as a nonconformity), the organization will determine the significance, risk of the nonconformity and the potential of recurrence. Once this has been determined, the organization may decide that the nonconformity has little associated risk or is unlikely to recur. In such cases, the organization may decide only to carry out a correction. Should the nonconformity recur during manufacturing or after product has been delivered to a customer, it is an indication that an improvement action is likely to be required. In either case, a Quality Management System (QMS) requires that corrective action(s) be carried out with the aim of preventing recurrence. Corrective actions (CAs) may be quite simple, or as complex as redesigning the manufacturing process.
Organizations may also encounter situations that have not actually caused a nonconformity, but may bring one in the future. Such situations call
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How do we define Enterprise Quality Management Software in 2011?
Written by Don Giesen, Strategic Advisor, Sales
We define Quality Management Software as an enterprise web based solution created to electronically manage quality operations in a cost effective way. The software needs to be designed in a scalable architecture fashion in order to be able to support operations for a few hundred employees locally or thousands globally.
Also, it needs to align with industry standards in terms of leading hardware, software and operating systems. The solution must be part of a global enterprise system and, therefore, seamlessly integrate with other critical systems such as ERP, MES, LIMS and CRM systems. This systemic approach will allow companies to be supported by a complementary enterprise suite of solutions to support quality operations.
In the end, Quality Management software should bring true value to the enterprise by increasing operational efficiency and levels of compliance. The software should be as easy as possible to implement, use and maintain. Therefore, working with a company who brings not only a great product to the table but also provides you with a team of knowledgeable professionals in areas such as automated quality processes, project management, validation, data migration and training will ensure a successful transition to an automated environment.
