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Download "7 Steps to Effective CAPA"

Download the 7 Steps to Effective CAPA Whitepaper!

Your company can avoid regulatory sanctions and reap the benefits of a streamlined CAPA program by implementing these 7 key strategies.

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Corrective & Preventative Action Software (CAPA)

A closed-loop Corrective Actions and Preventive Actions (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 CAPA software 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 software documents

 

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

 

 IBS Corrective Action Software

 

 

Problem:

 

 

Solution:

 

 

 

Searching for the root causes of product and process issues requires major effort.

 

Resulted in: Days of shifting through documentation (i.e., customer calls, design files, incident reports, etc.) to attempt to identify related incidents and patterns. 

 

 

  • The CAPA software system makes it easy to locate documents through search and retrieval.
  • Employees can follow clear-cut investigation plans to identify root cause.
  • Employees can access a vast repository of documentation to pinpoint cause with enterprise compliance software.
  • Customers see significant reduction in the cycle times of corrective actions.

 

 

 

After closing corrective actions and preventative actions, companies often failed to evaluate the effectiveness of the actions they took.

 

Resulted in: Companies not knowing if they truly ever resolved problems, or whether additional steps could have been taken to eradicate future issues without intuitive workflows for CARs and PARs. 

Also causes problems with registrars and regulatory agencies, as auditors want to see evidence of effective CAPA processes.

Lastly, this costs companies missed opportunities to improve quality processes.

 

 

 

 

 

  • CAPA Software system has intuitive, powerful tools to help users assess the effectiveness of their actions. 
  • Proposes changes to related processes based on CAPA software findings.
  • Users continuously improve their quality processes, improving integrity of company products and drive up customer satisfaction.

 

 

Without a centralized system for recording quality information, it is difficult to to spot troubling trends. 

 

Resulted in: 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.

Even if problems are not nonconformances, they can still slow efficiency and affect product quality.



  • All company product and process-related documents now stored in easily accessible, centralized area.
  • Quality managers can create reports and assessments, and launch preventative actions based on findings with CAPA software.




 

Proactive companies do more than damage control - they strive to identify potential problems before they become real problems.

 

Contact IBS today to find out more information.