Corrective and Preventative Actions is at the heart of any quality program. An efficient CAPA system reduces audit time, decreases risk of product recalls, improve product quality and safety, increases customer success and helps to ensure compliance. A digital and automated CAPA solution will uncover trends, solve process problems, and provide new preventative actions.
An automated CAPA established the mechanism to perform finding the root cause of a problem, devise a short-term fix and implement a long-term solution to prevent recurring problems.
Don't delay the resolution to an incident due to an inefficient system or human error. Intellect's robust out-of-the-box CAPA app enables organizations to establish and maintain procedures to collect and analyze information, identify and investigate product and quality problems, including root cause analysis, and take appropriate and effective corrective and preventative actions to prevent their recurrence.
Automatically overcome bottlenecks, send automated email notifications and reminders, and generate Corrective and Preventative Actions (CAPAs) and Supplier Corrective Action Requests (SCARs).
Intellect's CAPA Analytics console provides meaningful insights and reports on real-time CAPA activities created, in progress and closed by the user. Company metrics include various charts on total open and closed CAPAs by year, location and classification.
The process starts with capturing a failed incident. When a new record is created, Intellect automatically assigns an unique number for each corrective action record. The corrective action initiator starts with forming the team and describing the problem in quantifiable terms. A quality review determines if a corrective action is warranted and meets the requirements of standard operating procedures.
Typically, an interim immediate action is taken before a permanent corrective action has been determined. A thorough root cause analysis and risk assessment is performed by an investigator to determine corrective actions and defines the effectiveness verification plan.
The quality team reviews and approves both the corrective action and effectiveness verification plan before permanent corrective actions are taken. The process then moves to an active implementation phase where a permanent corrective action is taken, and the team validates whether the solution is effective.
Intellect's robust CAPA app is part of Intellect QMS 4.0 and no-code platform offering. Intellect's extreme configurability is designed to empower quality leaders to achieve their goals without burdening IT. Users can drag-and-drop and point-and-click to modify workflows, forms, and reports to meet their unique business or regulatory needs.
Manual systems leveraging excel or other homegrown solutions are inefficient, prone to human errors, and may delay the resolution to an incident. Intellect’s CAPA application automates and streamlines the entire process, from data collection, follow-up, escalation, and resolution of existing or potential nonconformances.
Users know when and what to do and can review tasks or complete approvals on any device, at any time. At the same time system overcomes bottlenecks, send automated email notifications and reminders that drive accountability and task completion.
Intellect offers a 8D problem solving methodology to facilitate continuous improvement through identifying, classifying, and eliminating existing or potential nonconformances in product, processes, and system.