Validation, Commissioning & Design Featured Articles

  1. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  2. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

    This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

  3. Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance 7/28/2025

    Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

  4. Understanding Modern Storage Tank Design And Fabrication 7/28/2025

    Industries rely on advanced storage tanks and pressure vessels to safely manage liquids, gases, and powders. Discover how custom-engineered solutions can enhance efficiency, safety, and compliance.

  5. Ensuring AI Compliance In Life Sciences: 5 Critical Requirements 7/24/2025

    Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.

  6. Why Established Pharma Sites Need A Digital Cleaning Validation Strategy 7/23/2025

    Pharmaceutical facilities face mounting pressure to modernize. Uncover how digital tools are transforming cleaning validation to boost compliance and audit readiness without disruption.

  7. The Benefits Of Automating Your Requirements Traceability Matrix 7/23/2025

    The Requirements Traceability Matrix ensures every system requirement is verified through testing, supporting compliance, reducing risk, and strengthening validation efforts across development.

  8. Stop Managing CQV In Silos: Unify Your Validation Systems 7/23/2025

    Fragmented CQV systems hinder validation efforts, which risks compliance and slows progress. Discover how centralized platforms streamline processes, boost efficiency, and meet evolving regulatory demands.

  9. How Intelligent Automation Transforms CQV Workflows 7/23/2025

    Discover how intelligent automation is revolutionizing CQV in life sciences to eliminate manual bottlenecks, accelerate timelines, and enhance compliance in an era of increasing regulatory scrutiny.

  10. AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies 7/23/2025

    A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.