White Papers

  1. Validation And Qualification Approach In New Annex 1 Revision 2/21/2025

    The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

  2. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

  3. Supplier Quality And The True Cost Of Recalls 2/20/2025

    Recalls can cost millions (or even billions) and threaten a company’s public perception. Discover how to minimize recall costs and enhance compliance with effective quality management strategies.

  4. Quality: The Link Between Platform, Processes, And Patients 2/18/2025

    Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.

  5. Connecting Quality Management, Patient-Centricity, And Business Value 2/18/2025

    Examine why organizations must integrate data and processes to enhance quality and insights to improve operational efficiency, patient health, and regulatory compliance.

  6. Leveraging Life Sciences Data For Intelligent Decision-Making 2/18/2025

    Industry 4.0 drives life sciences to prioritize data-driven decision-making by integrating advanced technologies in QMS. Discover how modern data management can improve compliance.

  7. Three Key Strategies To Guide Efficient And Effective Recall Management 2/18/2025

    Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.

  8. OEE And Product Inspection 2/13/2025

    Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.

  9. Modular Automation: The Plug-And-Produce Opportunity For Life Sciences 2/12/2025

    Explore how the advantages of modular automation in life sciences emphasize flexibility, efficiency, and cost savings through plug-and-produce systems that enhance production adaptability and speed.

  10. Leveraging Digitalization To Resolve CGT Manufacturing Challenges 2/12/2025

    Uncover digitalization's role in overcoming manufacturing challenges in cell and gene therapies to enhance efficiency, quality, and scalability through data analytics and real-time monitoring.