Validation, Commissioning & Design Featured Articles

  1. Responding To Fill-Finish And Automation Scale-Up Challenges 5/21/2025

    Behind every life-saving cell therapy is a complex manufacturing journey. Examine the critical role of automation in overcoming production challenges and ensuring quality.

  2. Why Biotech Leaders Can't Afford Delays In Document Review 5/15/2025

    Document review is a hidden bottleneck in biopharma. Learn how inefficiencies in this critical process can delay drug development and what you can do to accelerate time to market.

  3. The 3 Phases of QRM – An Inspector's View 5/14/2025

    Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.

  4. Addressing Human "Error" In Pharma Manufacturing 5/7/2025

    Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.

  5. Why Manual CQV Costs More Than You Think 5/6/2025

    Discover how modernizing commissioning, qualification, and validation processes in pharmaceutical and biotech manufacturing can streamline operations, reduce risks, and enhance efficiency to ensure compliance.

  6. 7 Reasons To Embrace AI-Enabled Digital Validation 5/6/2025

    Are you overwhelmed by paperwork during validation projects? Discover how AI-enabled validation can streamline operations, strengthen compliance, and keep you ahead in the fast-paced pharmaceutical and biotech industries.

  7. The Future Of Compliance, Efficiency, And Data Integrity 5/5/2025

    Explore how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.

  8. Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis 5/5/2025

    Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.

  9. 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.

  10. Contamination Control Strategies For Regulatory Compliance 4/24/2025

    Discover how a robust Contamination Control Strategy (CCS) can mitigate contamination risks and gain insights from Ugo Omeronye's detailed responses in our comprehensive reference guide.