CAPA Management in LuitBiz QMS
You can use the Quality Form Creation feature of LuitBiz QMS to create Corrective and Preventive Action (CAPA) forms based on your industry requirements. Every Quality Management system revolves around CAPA. CAPA management is a crucial aspect of regulatory inspections. An automated CAPA system cuts down on audit time and results as well as the likelihood of product recalls. It raises customer satisfaction, boosts product quality and safety, and assures regulatory compliance.
CAPA Challenges and how LuitBiz QMS can help
Without LuitBiz QMS
With LuitBiz QMS
Inefficient Corrective Action
Manual document control is might be cost-effective initially, but in the long run they turn out to be inefficient and costly. They require tremendous man-hours in terms of routing CAPA tasks and other documentation, obtaining approval and signatures, and manual search and retrieval of documents during inspections and audits.
Efficient System for Corrective Action
Customized CAPA forms created in LuitBiz QMS with attached workflows automate routing, notification, delivery, escalation, and approval of CAPAs and all related documentation. The entire CAPA process from initiation, investigation and closure is automated using the CAPA forms of LuitBiz QMS. Additionally, all the related CAPA documents can also be stored centrally in the same web directory making it a secure repository for all CAPA related documents.
Disconnected CAPA Processes
A CAPA may be triggered by audits, customer complaints or some other events in the quality process. These sources are not connected in manual and hybrid systems, which slows down and omits some data from data collection. Without connectivity, important data could get lost and the root cause analysis would probably be inaccurate.
Connected CAPA System
The holistic approach of the CAPA forms of LuitBiz QMS integrates the corrective action and preventive action processes with the rest of the quality system. For example, the resolution of a corrective action will trigger an engineering change, an SOP change, and retraining of employees on the new SOP.
Poor CAPA Reporting
There is no assurance that all crucial information will be captured when customer complaints, deviations, adverse events, and other incidents that can lead to a CAPA are gathered manually because paper reports are lost easily and takes a long time to update. Re-entering data from hard copy into an electronic system is necessary for a hybrid system, and this procedure is prone to errors and delays.
Disconnected CAPA Processes
To expedite the CAPA process and prevent errors while re-entering data, a CAPA form can be attached to another form (such as a customer complaint form, etc.) using the LuitBiz QMS. Links are kept up to date so users can evaluate a finished procedure and quickly determine what caused the CAPA.
Lack of CAPA Oversight
Poor implementation of CAPA systems a top reason for issuance of non-compliance notices like FDA Form 483. It is mainly due to the lack of ability to track and monitor open CAPAs and proactively improve the CAPA process.
Increased oversight with automated CAPA
Customer complaints, audit results, and other quality incidents that potentially develop into CAPAs are tracked by the Quality Forms of the LuitBiz QMS. Reports and cutting-edge analytics are provided by the system. Managers may take a more proactive approach to enhancing their quality system using these reports, which provide a real-time perspective of the CAPA process.