Insights On Quality Assurance

  1. Three Vital Steps To QMS Implementation 11/7/2024

    When selecting a QMS, it may feel like the most challenging step is making the purchase. This is not necessarily the case. Read more about the challenges of implementing an effective QMS.

  2. Why The Regional Site Manager Is The Swiss Army Knife Of Clinical Trial Monitoring 1/28/2025

    The Regional Site Manager (RSM) monitoring model eliminates numerous clinical trial risks by leveraging efficient, start-to-finish site management by a single, expert point of contact.

  3. Validation And Qualification Approach In New Annex 1 Revision 2/21/2025

    The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

  4. Can Today's ELNs Support Tomorrow's Labs? 3/14/2024

    The global electronic laboratory notebook (ELN) market is growing, however, ELNs must form part of a more comprehensive data strategy and ecosystem or they can impede progress.

  5. Getting CMC Right For Emerging Technologies 12/20/2023

    Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

  6. Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence? 9/5/2023

    Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

  7. Nasal Inhalation Delivery – An Introduction Guide 10/21/2024

    Unlock the potential of nasal inhalation for delivering active pharmaceutical ingredients by exploring the benefits of both liquid and dry powder formulations as companies drive innovation in the field.

  8. Cambrex Scientist Spotlight: Jonas Nilsson 1/29/2025

    Jonas Nilsson, Principal Scientist based in Karlskoga, Sweden, leads a team of synthetic chemists focused on process development and optimization.

  9. MilliporeSigma's 97-Day Implementation Success Story 3/19/2025

    Discover how MilliporeSigma transformed validation processes with a digital validation system to achieve efficiency and compliance in just 97 days as well as learn key takeaways from their swift transition to digital validation.

  10. Adapting To Evolving Regulations: Validation In A Changing Landscape 3/26/2025

    Discover how evolving regulatory expectations in life sciences present new challenges and opportunities, as well as gain insight into strategies from experts in the field to navigate risk-based validation processes.