CAPA Management Solutions for Life Sciences

FDA inspectors and ISO auditors view CAPA - Corrective Action / Preventive Action - as critical to investigating and correcting quality issues, and ensuring there is no recurrence. The QUMAS CAPA Solution provides a closed-loop process for effectively managing the corrective action/preventive action process and integrating it with other processes critical to regulatory compliance, such as change control, audit, and customer complaints. This closed-loop approach to compliance automates the generation of internal or external complaints, product non-conformances, deviations, audits, investigations and all other actions. From initiation to closure, the QUMAS Solution captures, records, routes, verifies completion and approvals all while auditing each step in the entire CAPA process.

Benefits

  • Track incidents and record the root cause of Corrective Action and Preventative Action Requests
  • Leverage internal incident forms throughout your company and at any location, department, or site to create, submit and route incidents, complaints, hazards and issues in accordance with your business rules and structure
  • Create and assign multiple action items to users for executing and supporting the root cause analysis process with due dates, definitions and email notifications
  • Launch a CAPA form directly from another form (i.e., deviation report, customer complaint, etc.). Links are maintained so users can review a completed process and see what triggered the CAPA
  • Leverage automated data entry -- relevant data from a form that could potentially require a corrective action is automatically entered into a CAPA form, reducing data entry and eliminating errors from manually transferring information
  • Benefit from a secure, centralized repository for all CAPA documents
  • Update affected SOPs within the same solution, with direct integration to the CAPA tasks

For more information on managing CAPAs using the QUMAS QMS, download this webinar on QUMAS Quality Management Solution for Global Regulatory Compliance, which outlines how to take control of your quality processes including CAPAs, Deviations, Change Control and Audits:

  • CAPA creation
  • Form filling, workflow execution
  • Root Cause Analysis
  • QA Approval

Alternatively, check out this CAPA Process Package from the QUMAS Packaged Solutions, which offers an off-the-shelf approach to CAPA Management.