Quality & Manufacturing Innovation

Our solutions empower you to realize competitive advantages throughout the value chain while minimizing exposure to risk. We offer industry-leading innovation toward compliance management and risk mitigation across quality & manufacturing. Our approach enables manufacturing facilities to produce life enhancing products in a more efficient manner, with higher safety standards, and reducing costs and time to market.

Quality & Manufacturing Innovation Value

Our clients in manufacturing look to us when they are challenged to meet the rising standards for quality driven by rigorous and ever-evolving regulatory requirements.

Before a drug product can be commercialized, the manufacturing process, including all key unit operations, must be validated and shown to repeatedly produce acceptable outcomes.  Achieving this state includes effective management of risk throughout scale-up and production while ensuring adherence to the process and product specifications filed with the FDA.

Paragon’s Quality & Manufacturing Information Management Framework Solution Sets provide in-depth industry leading capabilities that integrate the key information in this complex environment.  The result is seamless management, of product & supplier quality processes and a greatly improved compliance posture.

By enabling our customers to effectively assess risk and accelerate the identification and resolution of issues, our solutions maximize value across the product lifecycle. 

See how we can help your business.
Our solutions are industry-targeted and designed to assist those who want to:
  • Efficiently and effectively manage GXP Quality Systems documentation throughout the life of their products.
  • Reduce the cost of quality operations and systems, while enhancing compliance and process efficiencies.
  • Comply with the FDA’s quality metric collection programs and regulatory guidance.
  • Measure risk quantitatively and uncover factors critical to managing and reducing risk in the manufacturing environment.
  • Improve quality, internal efficiencies, cost reductions and cost avoid­ance; improve employee engagement, and the ability to leverage a diverse, global, interconnected quality & manufacturing network.
  • Enhance preventative and reliability maintenance programs and automate risk-based training for optimal efficiencies and safety.
While our solutions are unique to your needs and current position, our services typically offer the following benefits:
  • GXP Content Management
  • Quality Analytics
  • Quality Metrics
  • Knowledge Management
  • ECM Strategies
  • GMP Validation
  • Migrations
  • Archiving
  • Process Optimization
  • Change Management
  • Plant Floor Automation & Maintenance
  • Plant Floor Training Automation

Thought Leadership in Life Sciences

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