Insights On Quality Assurance

  1. Technology Transfer And The Need For Digital Transformation 10/4/2024

    The right data management platform can streamline biopharma technology transfer by bridging digital gaps, accelerating commercialization, ensuring compliance, and reducing costs.

  2. The Role Of The Technical Transfer Executive Sponsor 10/30/2023

    Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

  3. Are You Aligned With FDA's Computer Software Assurance Methodology? 3/19/2025

    Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.

  4. Leaving Spreadsheet Based Quality Management Behind 2/7/2025

    Transitioning from spreadsheet-based quality management to advanced digital systems can benefit companies. Explore key advantages such as improved accuracy to drive better organizational performance.

  5. A Rapid Approach For Moisture Determination Of Lyophilized Product 11/13/2024

    Explore the limitations of traditional moisture determination techniques, an innovative approach using laser-based headspace analysis, and real-world case studies using this non-destructive method.

  6. The Importance Of Vendor And Supplier Quality Management 9/20/2024

    Explore the importance of supplier quality management, relevant standards, regulatory audits, best practices, and the overall significance of this practice within the life sciences sector.

  7. Characterizing The Effects Of Moisture On Pharmaceutical Materials 12/30/2024

    Moisture impacts pharmaceutical ingredients’ stability and efficacy, causing phase changes and hydrate formation. Discovery SA enables humidity and temperature profiling for improved drug formulation.

  8. 6 Reasons To Transition To A Cloud-Based Lab Data Management System 7/3/2024

    Dig deep into some of the compelling reasons to move from on-premise to a cloud-based laboratory data management system.

  9. Understanding ISO/TR 14644-21 Airborne Particle Sampling Techniques 2/26/2025

    Industry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.

  10. Why And Where To Monitor In Aseptic Processing Areas 4/24/2025

    Annex 1 mandates a risk assessment to identify optimal sample point locations. Explore factors in risk assessment, equipment selection, and system design to maximize data value.