Software for Automating the CAPA Process
A Corrective & Preventative Action tracking software system is a regulatory requirement that both FDA/ global regulatory inspectors and ISO auditors consider critical and is the focal point of any quality system. When implemented properly, a Corrective Action software system improves product quality and safety, increases customer satisfaction, and more importantly, ensures FDA and ISO compliance.
Labcore's Corrective Action - CAPA software system is a scalable, easy-to-use
system designed to effectively manage the corrective action / preventive action
process and integrate it with other quality processes critical to regulatory
compliance, such as change control, audit, and customer complaints. 
Here's how the CAPA system from Labcore addresses some of the major challenges that companies face in establishing and maintaining effective corrective action and preventive action processes:
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Pain Point/Challenge: Inefficient System for Corrective Action - Paper-based and hybrid systems for Corrective Action and Preventive Action are inexpensive initially. In the long term, however, these systems are inefficient, requiring 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.
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Labcore Solution: Efficient System for Corrective Action - Labcore’s software system automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation with configurable workflow. It automates management of entire CAPA process, from initiation to investigation and all the way through closure. Provides a secure, centralized, and Web-based repository for all CAPA documents |
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Pain Point/Challenge: Disconnected CAPA Processes - A Corrective Action and Preventive Action (CAPA) may be triggered by Form 483 findings, ISO quality audits, customer complaints, or some other source. With manual and hybrid systems, these sources are not connected, making data collection slow and incomplete. Without connectivity, critical information may fall through the cracks, and the root cause investigation is likely to be unreliable. |
Labcore Solution: Connected CAPA Management Software System - The MasterControl CAPA software integrates the corrective action and preventive action processes with the rest of the quality system for a holistic approach. For example, the resolution of a corrective action will trigger an engineering change an SOP change, and retraining of employees on the new SOP. |
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Pain Point/Challenge: Poor CAPA Reporting System - When customer complaints, deviations, adverse events, and other incidents that can trigger a Corrective Action and Preventive Action (CAPA) 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 copy into an electronic system, a process prone to delay and mistakes. |
Labcore Solution: Efficient CAPA Reporting Software System - With Labcore CAPA solution, a CAPA form provided by Labcore or modeled exactly on an existing form in use at the lab is used to streamline the CAPA process and avoid mistakes during re-entry of data. Links are maintained so users can review a completed process and easily see what triggered the CAPA and data validation and workflow enforce data structure and eliminate error |
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Point/Challenge: CAPA System: Lack of Oversight - Poor implementation of Corrective Actions and Preventive Actions (a top reason for issuance of a Form 483) may stem from the lack of ability to track and monitor open CAPAs and proactively improve the CAPA process |
Labcore Solution: Increased Oversight - Labcore CAPA solution tracks quality incidents that can escalate into a CAPA, such as customer complaints, audit findings, etc. Through a personalized homepage dashboard, managers get a real-time view of the CAPA process and can be more proactive about improving their quality system. |
