Insights On Regulatory Compliance

  1. Revolutionizing Pharma Validation With AI 5/28/2025

    Validation in GxP environments is often the bottleneck in digital transformation—manual, repetitive, and complex. One company's Intelligent Agents are transforming that process.

  2. 3 Key Considerations In Gene Therapy Manufacturing 7/15/2025

    Viral vector-based gene therapies are redefining medicine. As developers navigate uncharted territory, Sybil Danby of Cytiva highlights three critical areas shaping the journey from discovery to patient access.

  3. Why Choose The Identifier Software? 7/18/2025

    Unlock Pharma 4.0 for injectable drug inspection. Learn about a system that transforms data management, offering immediate access and global regulatory compliance.

  4. Generation Of A Contamination Control Strategy 8/16/2025

    An unaddressed compliance issue related to contamination control can pose a significant risk to a life sciences organization. This case study details a company's journey toward sustainable compliance.

  5. Quality, Compliance, And Validation In The Digital Transformation Era 9/4/2025

    Discover how life sciences companies can confidently embrace digital transformation. Gain practical strategies from experts to modernize quality, compliance, and validation—without the overwhelm.

  6. 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.

  7. EU ANNEX-1 And The Impact Of Contamination Control Strategy On Cleaning & Disinfection 10/21/2024

    New EU rules tighten grip on contamination control for sterile drugs. Learn how to ensure your cleaning and disinfection meet the stricter standards.

  8. Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines 8/6/2025

    As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

  9. Label-Free Analysis Of Multiple Spheroids In A Matrix 11/7/2025

    Gain insight into how automated z-stack imaging and AI-based analysis enable accurate, label-free monitoring of spheroid development in 3D matrices for drug screening and cell culture workflows.

  10. De-Risking The Transition From Vial To Drug-Device Combination Product 7/25/2025

    When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.