Compliance Management Featured Articles

1. Tobias Struller, Manager, Process Performance & Qualification 12/4/2025

   Tobias provides insight into the challenges of manufacturing cytotoxic and noncytotoxic drugs together in a multiproduct facility.

2. Human Performance In Pharma: Strengthening The Biotech Workforce 11/24/2025

   Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.

3. From Day One Success To Everyday Improvement: The OR → OE Continuum 11/24/2025

   Bridging the gap between initial startup and long-term sustainability requires a unified strategy. Learn to transform early readiness metrics into a durable operating system that drives continuous performance improvements.

4. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

   The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

5. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

   A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

6. Confessions Of A Microbiologist: What I Wish I Had Known For Our Facility Shutdown 11/17/2025

   Facility shutdowns often compromise contamination control strategies. Transitioning from manual cleaning to automated bio-decontamination ensures a more effective facility restart, eliminating persistent mold risks.

7. How To Improve Sponsor–CMO Collaboration Around Digital Deviations 11/17/2025

   Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.

8. Operational Readiness Frameworks For Pharma And Biotech 11/14/2025

   Achieving top performance in life sciences requires a continuous journey from Operational Readiness (OR) to sustained Operational Excellence (OE), ensuring safe startup and long-term efficiency.

9. Viral Vector Technology Transfers: A Guide To Success 11/13/2025

   Strategic, well-aligned partnerships between sponsors and CDMOs are key to efficient, scalable viral vector technology transfer.

10. 3 Reasons Why Manufacturers And CDMOs Are Integrating QA, QC, And Manufacturing 11/5/2025

    Life sciences manufacturers are integrating QA, QC, and production to boost efficiency, reduce downtime, and scale smartly. Discover how Industry 4.0 technologies are reshaping operations.