Quality (CAPA) Management

Identify, Resolve and Analyze Quality Issues

Product development companies are acutely aware of the impact that product defects and problemscan have on customer satisfaction and their reputation.

Automated quality systems provide a vehicle for companies to resolve problems quickly, and supply invaluable reporting for performance metrics and trend analysis to help improve operations. For many companies, such as those in the Life Science/Medical Device industries, structured quality systems are a mandate for FDA approval/clearance.

The Omnify PLM Quality Management module is integrated with all product data stored in Omnify, offering a unified location to manage product and quality data. It is a closed-loop Corrective and Preventive Action (CAPA) system that provides users with the ability to capture and route (for resolution) any product defects and issues.

The Quality Management module consists of forms, reports, and alerts to classify and analyze product problems. Quality forms can be created and classified to represent any type of problem, such as: Corrective Actions (CAR), Preventive Actions (PAR), Supplier Corrective Actions (SCAR), Non-Conforming Materials Report (NCMR), and Customer Complaints.

Benefits of Quality Management

  • Assure Good Manufacturing Practice (GMP/CGMP) and Regulatory Compliance
  • Improve product quality
  • Eliminate recurring product issues
  • Reduce development cycles by avoiding prior development/product issues
  • Single database to associate quality issues with product data records
  • Enhance visibility of quality issues across all teams

Download the Omnify PLM Quality Management Datasheet