Quality and CAPA Management

The process of dealing with quality issues, such as Corrective and Preventive Actions (CAPA) and product complaints is the single greatest source of regulatory risk for Medical Devices manufacturers today. The process gets bogged down in the minutiae of documentation and fails to adequately address the critical issues regarding risk, root cause and remediation.  Medical Devices manufacturers and other Life Sciences organizations consistently struggle to deal with quality issues efficiently and effectively. And as the complexity of products and processes increases, this predicament only promises to worsen. Meanwhile, medical devices manufacturers are not getting the strategic value they should from the vast resource of valuable feedback collected in their quality systems.

Dassault Systemes (DS)’ solution for Quality Issues & CAPA Management provides medical device manufacturers the ability to effectively and efficiently manage quality issues by improving QSR/GMP/ISO compliance while eliminating non-value-added waste.  The solution manages all quality issues through a single, global, on-line system to provide insight into the health of your CAPA process.  As a result, companies will avoid compliance risk, reduce waste and increase the interconnectedness of team members and business processes. This solution addresses two critical concerns for Life Sciences companies: CAPA and product complaints.  

DS Solution for Quality Issue and CAPA Management includes:

  • CAPA investigations
  • Nonconformance reports
  • Product complaints
  • Quality audits

ENOVIA has proven particularly valuable in helping us model our business process, which it does very well. As a relational database, it enables our people to work through the details of a business process and apply it through a schema

Stephen Wells Design and Documentation Manager, Terumo Cardiovascular Systems