Quality, Compliance and Innovation

Pharmaceutical Industry Status

Stringent regulations, complex and multi-disciplinary development and production processes, comprehensive research trials, along with associated risks, are mission-critical challenges facing today’s global pharmaceutical processors. Companies must operate efficiently as possible to manage cost, minimize risk and maintain compliance. In such an environment, lack of cross functional collaboration between teams and processes makes it difficult to manage the increasing complexities in each phase – especially complying with mandates throughout the product development process.

Critical to success is improving visibility into materials specifications, requirements, models, etc. which increases efficiency, minimizes risk as well as cuts time and cost.

PLM for Compliance, Quality


Read insight from industry analysts CIMData at how PLM supports the dynamic enterprise.

Leading pharmaceutical firms benefit from a new approach to regulatory compliance, quality, increased traceability, change management, and the ability to track product information across brands.

The core capabilities of Aras solutions, which include configuration and change management, project and requirements management, and quality planning, provide the pharmacy industry with visibility into the product lifecycle across all disciplines. And as business and processes change, Aras is built to adapt to evolving needs.

The Aras Value for Pharmaceuticals

Pharmaceuticals companies can drive quality and innovation, reduce risk and manage regulatory compliance.

  • Best Practices for Global Product Development, including Formulation Management, Process Automation and Optimization, Clinical Trials, Secure Data Exchange, and Packaging and Labeling
  • Standards, Quality, Safety and Regulatory Compliance, including Lean, FEMA, CAPA, 21 CFR Part 820 Quality System Regulation, 21 CFR Part 11 Compliance, ISO 13485, and the European MDD (2007/47/EC)
  • Business Intelligence and Analytics, including Reports, Scorecards, Dashboards and KPI Metrics
  • Flexible, Easy to Use Web-based Environment with Intuitive Microsoft Look and Feel

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