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Biopharma Quality and Compliance


Quality helps ensuring patient safety, treatment efficacy, sustainability and protection of brand reputation. Dassault Systèmes helps achieving Quality and Business Excellence with a new a comprehensive data-centric approach to Quality, ensuring digital continuity, data integrity and a “Single Source of Truth” of information. The integrated capabilities include Quality Document and Content Management with automated tasks, electronic signatures, standardized controlled processes and audit trails, Quality Process Management (like CAPA investigations or root-cause analysis) with 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 provides full regulatory compliance, has a modern and intuitive user interface and is easily 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