Validation, Commissioning & Design Featured Articles

  1. One Less Risk: Why ISO 27001 Certification Matters For Your FDA Audits 3/23/2026

    ISO 27001 certification offers independently verified security controls that reduce qualification burden. Learn how this framework supports Part 11 compliance, GAMP 5 validation, and audit readiness.

  2. Purpose Built Calibration Management In Life Sciences 3/23/2026

    Discover how purpose-built calibration platforms automate compliance through native OOT workflows and NIST traceability, while generic ERP systems require extensive customization.

  3. Generative AI Can Write The Code, But Who Builds In The Quality? 3/23/2026

    Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

  4. Quantifying Endotoxins Via Absorbance Or Fluorescence 3/20/2026

    Find out how endotoxin assays use Factor C activation to generate measurable absorbance or fluorescence signals, with guidance on selecting detection formats and implementing scalable workflows.

  5. Empowering Glove Integrity Testing: Successful End User Training On The Esco IntelliGlove Tester (EIGT) In Bangladesh 3/19/2026

    Advanced wireless testing ensures glove and barrier integrity in sterile manufacturing. These tools support ISO compliance and Annex 1 standards to strengthen contamination control.

  6. Ensuring Performance And Compliance: Successful FAT Of Filling Line Isolator For Creative Lifesciences, Taiwan 3/19/2026

    Rigorous Factory Acceptance Testing ensures filling line isolators meet performance and safety standards. This validation is vital for aseptic integrity and protecting both product and operator.

  7. 5 Minutes With: Jeff Goldman, General Manager 3/16/2026

    A look at the motivations, challenges, and vision shaping a new approach to life science tools—focused on practical design, thoughtful engineering, and expanding access to technologies.

  8. Future-Ready Process Control: Enabling AI And Digital Transformation In Pharma 3/16/2026

    Failing to innovate limits your agility and adaptability. When implemented thoughtfully, AI and automation can improve integration, efficiency, and compliance without compromising integrity.

  9. Dalton Pharma Service's Integrated Single Site Model 3/16/2026

    A fully integrated single‑site model unifies development, manufacturing, formulation, fill‑finish, and quality oversight to reduce handoff risk and speed progression from API to sterile drug product.

  10. Pharma's Guide To Navigating Complex Impurity Compliance And Profiling 3/16/2026

    Evolving regulations require proactive impurity control using trace‑level detection, solid risk assessment, advanced analytics, and ongoing monitoring to prevent compliance issues.