MasterControl's CAPA Procedure - Corrective Action Process Systems are designed by industry practitioner for automating the CAPA process in any organization. A CAPA system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated CAPA system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.
CAPA (Corrective Action / Preventive Action) is often used synonymously with 'corrective action procedure'. A CAPA -- the overall effort to investigate and correct quality issues to prevent recurrence -- is the lynchpin of any quality system. It is a regulatory requirement that both FDA inspectors and ISO auditors consider singularly critical. When implemented properly, a corrective action procedure improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.
A corrective action process is not reworking or remaking an item to bring it back into specification. Patching up a mistake doesn't address what made it happen in the first place and it won't prevent a recurrence.
A CAPA procedure can be documented using either a paper or electronic system. Either way, the process is basically the same:
Automating the above steps greatly facilitates the completion of the CAPA process.
MasterControl CAPA automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation. It automates management of entire corrective action procedures, while providing a secure, centralized, and web-based repository for all CAPA documents.
For additional details about the Document Control Software Systems from MasterControl, please feel free to contact a MasterControl representative.