Insights On Regulatory Compliance

  1. Optimal Microbial Sampling Criteria 6/24/2025

    Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

  2. Computer Software Assurance: A Game-Changer For Life Sciences Compliance 9/18/2025

    CSA offers a smarter, risk-based approach to software validation that reduces documentation burdens while enhancing product quality. Learn how teams are using it to accelerate digital transformation.

  3. Pharma Company Digitizes Paper Logbooks To Increase Data Accessibility 9/18/2025

    A top pharma producer modernized its operations by digitizing paper-based logbooks. Discover how this shift supports compliance and scalability across global manufacturing environments.

  4. Best Practice Approaches To Operational Readiness 12/11/2024

    Learn how to implement a focused operational readiness model that goes beyond traditional construction and startup schedules. Discover how this approach can reduce timelines and improve project success.

  5. Molecular Approaches To Streamline Cell Therapy Product Analytical Testing 9/26/2025

    Learn how rapid molecular methods of cell therapy testing like qPCR for mycoplasma, sterility, and lentiviral quantification are key to accelerating product release and timely treatment delivery.

  6. Top Safety Considerations In Biopharmaceutical Manufacturing 4/16/2025

    Understanding top safety concerns, from combustible material handling and chemical exposure to HPAPIs, is the first step toward preventing accidents in biopharmaceutical manufacturing environments.

  7. Prioritizing Data Security Through Digital Transformation 5/2/2025

    Integrating advanced digitalization solutions and prioritizing data security can accelerate drug development while reducing costs and ensuring consistency across a global network.

  8. How Robotic Isolator Technology Aligns To Annex 1 Principles 4/28/2025

    Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.

  9. Automation-Assisted Washing Of Multicellular 3D Spheroids 11/7/2025

    Automated washing of 3D spheroids improves consistency, reduces cell loss, and streamlines staining workflows. See how this approach enhances reproducibility and throughput in microplate-based assays.

  10. How Generative AI Streamlines GxP Compliance In Life Sciences 9/20/2024

    Generative AI is reaching a critical juncture in the life sciences industry. Learn how it is changing the game for GxP Compliance and enabling organizations to improve operational efficiency.