A closed-loop Corrective and Preventive Action (CAPA) system is a surefire way to improve product quality, drive customer satisfaction, and achieve compliance with ISO and FDA regulations. Yet many companies fail to communicate actions taken to all relevant parties, or to measure the effectiveness of their actions, leading to disjointed and duplicated efforts. As a result, poor handling of corrective and preventive actions is among the most frequently cited problems by auditors.

 

 

IBS Corrective Action Software enables users to streamline their CAPA processes, driving continuous improvement of quality processes. 

 

With IBS Corrective Action Software, you can:

• Create corrective actions from a number of different sources including NCMRs, customer complaints, assessments and incidents with automatic links between corrective actions and source documents
• Use the IBS pre-configured workflow or reconfigure the workflow to meet your specific company requirements
• Track the root cause, source and cost of your Corrective and Preventative Actions
• Track CARs and PARs by product, customer and supplier
• Create, assign and track multiple containment responses as necessary
• Escalate missed deadlines to responsible supervisors
• Automatically route actions to appropriate parties for approval
• Perform effectiveness reviews of your corrective and preventive actions
• Require secure electronic signatures with optional second password capability to meet the requirements of the FDA’s 21 CFR Part 11
• Choose from multiple options for securing document access based on individuals, groups or roles
• Access unalterable corrective and preventive action audit trails
• Choose multilingual access to your CAPA documents

Our Corrective Action solution is a tightly integrated part of our enterprise compliance management software, CompliantPro.

 

 

 

 

Before IBS Corrective Action Software: Searching for the root causes of product and process issues was a major effort. Shifting through documentation like records of customer calls, design files, and incident reports took days, and even then it was difficult to locate related incidents and patterns.

 

After IBS Corrective Action Software: The system makes it easy to locate documents through search and retrieval. Employees can follow a clear-cut investigation plan for identifying root cause. In an enterprise compliance system, employees can access a vast repository of documentation in order to pinpoint cause. Customers see vast reductions in the cycle times of corrective actions.

 

 

 

Before IBS Corrective Action Software: After closing corrective actions, companies often failed to evaluate the effectiveness of the actions they took. Without intuitive workflows for CARs and PARs, they never knew whether they truly resolved the problems, or whether they could have taken further steps to eradicate future issues. This caused problems with registrars and regulatory agencies – auditors wanted to see evidence of effective CAPA processes – and also cost them missed opportunities to improve quality processes.

 

After IBS Corrective Action Software: The system has intuitive, powerful tools to help users assess the effectiveness of their actions and propose changes to related processes based on their findings. Users continuously improve their quality processes, improving the integrity of their products and driving customer satisfaction.

 

 

 

Before IBS Corrective Action Software: Without a centralized system for recording quality information, it was difficult to spot troubling trends. Companies often took months or years to identify minor issues with products and processes that, if corrected, could have improved sales and strengthened company reputation.

 

After IBS Corrective Action Software: It makes a tremendous difference in companies’ efforts towards continuous improvement when they store all their product and process-related documentation in an easily accessible centralized area. Quality managers can create reports and assessments, and launch preventative actions based on their findings. Even if a problem is not a nonconformance, it can still slow efficiency and affect product quality. Proactive companies do more than damage control – they strive to identify potential problems before they become real problems.

 

 

 

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