Validation, Commissioning & Design White Papers & Case Studies

  1. Tackling The Cost Of Poor Quality: Strategies And Solutions 2/5/2025

    Don’t let the cost of poor quality hold your business back. Discover how a modern QMS can transform your operations and drive success.

  2. Incremental Adoption Of A Modular Operations Platform 1/31/2025

    Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.

  3. Challenges In Developing Medical Devices From Animal-Based Biomaterials In China 11/11/2024

    Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

  4. The Problem With Construction Quality 10/21/2024

    Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

  5. Developing Effective Procedures 10/21/2024

    Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

  6. Avoiding The Pitfalls Of PQR 10/9/2024

    Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."

  7. Design Testing Strategies To Develop A Drug-Device Combination Product 8/27/2024

    Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

  8. Solving The Silicone Challenge In Pre-Fillable Syringes 8/27/2024

    Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

  9. CMO Validation As A Service 8/20/2024

    Learn about the highly successful commissioning and qualification of Wheeler's Oklahoma City CDMO facility with the overarching goal of ensuring all equipment was qualified for a Phase 3 clinical production campaign.

  10. Aseptic Expertise And Delivery Of Services 8/20/2024

    A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.