FDA inspectors and ISO auditors view CAPA - the Corrective Action / Preventive Action process -- as critical to investigating and correcting quality issues, and ensuring there is no recurrence. When implemented properly, a CAPA system improves product quality and patient safety and increases customer satisfaction.

QUMAS is an easily configurable system that provides you with 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, QUMAS 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
• Internal incident forms enable users 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