Insights On Quality Assurance

  1. ICH Quality Risk Management Guidelines For Biopharma Manufacturing 11/27/2023

    Explore the key changes to the ICH Quality Risk Management guidelines that aim to optimize efficiency, effectiveness, and scientifically grounded control strategies.

  2. 5 Ways A QMS Reduces Cost Of Poor Quality 4/4/2025

    Discover how a robust Quality Management System can help your organization reduce the cost of poor quality while maintaining high standards and enhancing customer satisfaction.

  3. Is Your Pharma QMS Equipped To Handle Risk? 10/9/2024

    In a rapidly evolving industry, see why adopting digital solutions is essential for achieving operational excellence and staying competitive.

  4. 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.

  5. Six Benefits Of Automating A Manual Quality Management System 2/7/2025

    Manual processes often lead to inefficiencies and increased errors. Discover the six benefits of automating a Quality Management System to improve accuracy and enhance compliance.

  6. Quantifying Operational Excellence In The Life Science Industry: Part 2 8/3/2023

    Operational Excellence (OpEx) is crucial for organizations to prosper in this highly regulated and competitive sector. Here, we further explore the concept of OpEx and provide insights into its impact.

  7. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  8. Contamination Control Strategy With QRM Principles 11/19/2024

    Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

  9. Cambrex Scientist Spotlight: Ross McLellan 1/29/2025

    Ross McLellan, Team Lead for Solid Form Screening in Edinburgh, UK, leads a team dedicated to complex solid form screening and materials characterization for Cambrex’s global client base.

  10. Incremental Adoption Of A Modular Operations Platform 1/31/2025

    Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.