Insights On Regulatory Compliance

  1. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  2. A Roadmap To Expedited Review Pathways 6/12/2025

    Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. 

  3. Quality By Design: How Laboratory Capabilities Enhance CDMO Partnerships 8/20/2025

    Successful CDMO partnerships in sterile manufacturing depend on advanced laboratory capabilities, transparent collaboration, and integrated systems that transform challenges into advantages.

  4. Ensure Safety And Compliance With A Guide To Sterilization Validation 5/28/2025

    Sterilization validation is vital in pharma and medical device manufacturing to ensure product safety and regulatory compliance. Explore essential principles, best practices, and frameworks for effective implementation.

  5. Deviation And Change Control In Pharmaceutical Manufacturing 9/20/2024

    Explore deviation management and change control in the pharmaceutical industry, the elements of Corrective and Preventive Action (CAPA), and how to best approach these three interconnected processes.

  6. Easy Integration Of A New Manufacturing Platform 6/11/2025

    Easily integrate an innovative platform into your manufacturing process with seamless onboarding, regulatory support, and expert guidance that is designed to help you confidently adopt good manufacturing practices.

  7. What Is Aseptic Processing? 1/9/2026

    Aseptic processing sterilizes products and packaging separately, then combines them in a sterile environment. See how this method ensures safety, extends shelf life, and protects medicines from contamination.

  8. Viral Gene Therapy: Reducing Costs To Improve Patient Access 7/23/2025

    Gene therapy is revolutionizing medicine with its potential to cure genetic disorders. As approvals rise, so do concerns about accessibility, with million-dollar price tags limiting patient access.

  9. Inline Checkweighing Of Packaged Products In Manufacturing 12/29/2025

    Accurate inline checkweighing is vital for quality control. Learn how system design, software, and regulatory compliance work together to overcome high-speed production challenges.

  10. The Critical Role Of Product Inspection Systems In Manufacturing 4/21/2025

    Explore the vital role of product inspection systems in manufacturing as well as learn how checkweighers, metal detectors, and x-ray inspection ensure quality and safety across various industries.