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Biopharma Quality and Compliance


Quality is essential for patient safety, treatment efficacy, sustainability and protection of brand reputation. Dassault Systèmes helps organizations achieve Quality and Business Excellence with a new and comprehensive data-centric approach to Quality that supports patient safety, treatment efficacy, sustainability and protection of brand reputation—all based on digital continuity, data integrity and a “Single Source of Truth.” Integrated capabilities include Quality Document and Content Management including automated tasks, electronic signatures, standardized processes, audit trails and Quality Process Management (e.g., CAPA investigations or root-cause analysis). The system provides immediate access to data and documents with hyperlinks and Quality Intelligence using machine learning and federated search. Developed for the highly regulated BioPharma industry, this cloud-based solution supports full regulatory compliance with a modern, intuitive user interface and is readily scalable from only a few to 100,000 users.


  • Automate and streamline quality processes
  • Automate reporting with data-based structured documents
  • Manage quality processes and documents in one single system
  • Improve quality and integrity of data and documents
  • Minimize compliance risks
  • Reduce inspection time and downtime
  • Easily access all data and documents
  • Minimize Cost-of-Ownership
  • Gain meaningful insights for impactful decision making
  • Adopt a comprehensive, data-centric proactive approach to Quality