The Corrective and Preventative Action (CAPA) system is central to every Quality Management System (QMS). Quality professionals know the importance of managing CAPAs when a quality event occurs.
“CAPA is a well-known CGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence.”
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations, 2006
A functioning closed-loop CAPA system will help minimise product quality issues and ensure you are compliant with GMP regulations. However, many organisations struggle with managing such a system, working off disparate paper-based systems or paper/software hybrid systems.
When quality events such as customer complaints, deviations, adverse events and other incidents are collected manually, there's no guarantee that all critical information will be captured because it is easy to misplace (and time-consuming to update) paper reports. A hybrid system requires re-entering data from hard copies into an electronic system; a process prone to delays and mistakes.
As a Quality professional managing your CAPAs with a paper-based or hybrid system, you will find yourself spending a considerable amount of time manually:
- routing documentation and following-up approvals/signatures
- issuing and monitoring CAPA tasks
- tracking and updating the status of CAPAs and the related tasks
- gathering evidence and records to file with completed CAPAs
- searching for and retrieving relevant documents and evidence during regulatory inspections
Managing these critical tasks manually is like driving a car with a flat tyre; Inefficient and problematic. Without connectivity, critical information and tasks may fall through the cracks making the root cause analysis and subsequent CAPA unreliable leading to repeat qualilty events (requiring more time and effort) and potentially a regulatory deficiency.
“Failure to thoroughly investigate…” is a common finding from regulators such as the US FDA, TGA, HSA and Medsafe. Many GMP organisations struggle to demonstrate their investigative capabilities due to a malfunctioning CAPA system.
To address these issues that you may be facing, market leading software provider MasterControl has developed a closed-loop CAPA module that sits at the centre of its QMS platform. The system automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation. It automates management of the entire CAPA process, from initiation to investigation and all the way through to closure providing a secure, centralised and web-based repository for all CAPA-related records. The modular software integrates quality system elements to automatically track quality incidents that can escalate into a CAPA, such as customer complaints, audit findings, etc. for a holistic solution to effective Quality Management. The system provides advanced analytics and reporting capability, including customisable reports and online charting. Through the reports and dashboards, managers get a real-time view of the CAPA system and can be more proactive about improving the CAPA process and overall quality system.
SeerPharma is a strategic partner of MasterControl and has deployed this solution for many companies in the Asia-Pacific region.
For more information on how this solution could work for you, please visit:
You may also be interested in these related MasterControl posts:
- A Document Management System (DMS) to Achieve Document Control
- Learning Management System (LMS) for Pharmaceuticals & Medical Devices
- On the Road to More Efficient Manufacturing: A Digital Solution
- How Digital Production Records Can Build Quality Into Production
- How Digitization Can Help Life Sciences Manufacturers Amplify Lean Principles