Insights On Regulatory Compliance

  1. Sustainable Solutions For Medical Devices 1/6/2025

    Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

  2. Vision Inspection Software: The Missing Link In Digital Transformation 10/16/2025

    AI and MES can’t meet pharma’s visual inspection demands. Discover how purpose-built software ensures defect detection, compliance, and paperless quality for safer, more efficient operations.

  3. Streamlining pDNA: Capacity, Complexity, And Cutting-Edge Solutions 11/20/2025

    Learn how flexible facility design and process innovation are accelerating pDNA manufacturing, as well as key strategies to avoid scale-up pitfalls and meet growing therapeutic demand.

  4. High-Throughput Pyrogen Testing In A Multimode Microplate Reader 3/20/2026

    Explore a faster, high‑sensitivity approach to pyrogen detection that uses an NF‑κB reporter system to measure both endotoxin and non‑endotoxin contaminants to enable shorter workflows.

  5. 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.

  6. FDA's CSA Guidance Is Final: What It Means For Your Validation Strategy 3/23/2026

    Understand the FDA's shift from rigid CSV to risk-based software assurance. Binary risk classification and flexible testing approaches reduce validation timelines for production and quality.

  7. Supporting The Future Of cGMP Drug Product Manufacturing 12/22/2025

    Discover how holistic training and validation services help manufacturers navigate complex regulatory demands and achieve operational readiness faster.

  8. Proactive EAM Automation For Compliance And Efficiency 3/31/2026

    Proactive compliance depends on automation. When asset data drives investigations, enforces change control, and reveals hidden failure patterns, compliance becomes an outcome of strong operations.

  9. Dry Powder Media Manufacturing Grand Island Expansion 11/5/2025

    Take a video tour of our newly expanded dry powder media manufacturing facility in Grand Island, New York. The expansion has added more than 45,000 square feet of Animal Origin Free (AOF) manufacturing space to help meet increasing global demand.

  10. Separation Of cfDNA With An NGS Kit On Fragment Analyzer Systems 3/19/2026

    Learn how precise sizing methods reveal nucleosome patterns in cfDNA and help distinguish true signal from extraction‑related artifacts for more reliable genomic analysis.