Insights On Quality Assurance

  1. Getting The CAPA Framework Right The First Time 5/8/2024

    CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.

  2. How To Prepare For An Inspection: 8 Tips For Success 3/15/2024

    To achieve a successful inspection, organizations should adopt best practices. Examine these eight invaluable tools for inspection success.

  3. 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.

  4. In Silico Approaches Towards Automated Biomanufacturing 11/6/2023

    As part of MSAT, in silico approaches such as mechanistic modeling can be used to support and facilitate several activities in the production of biopharmaceuticals at all scales.

  5. Are You Aligned With FDA's Computer Software Assurance Methodology? 3/19/2025

    Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.

  6. 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.

  7. ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments 2/22/2024

    Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.

  8. A Rapid Approach For Moisture Determination Of Lyophilized Product 11/13/2024

    Explore the limitations of traditional moisture determination techniques, an innovative approach using laser-based headspace analysis, and real-world case studies using this non-destructive method.

  9. Regulatory And Quality Consulting, Operational Readiness Services 10/5/2023

    Learn how CAI aided a manufacturing company in merging food regulations with biopharmaceutical technology, allowing for the quick conversion of a small R&D facility into a GMP-compliant facility.

  10. The Power And Potential Of RBM In Clinical Trials 11/8/2023

    Risk-based monitoring increases overall trial oversight by balancing “must-do” data collection and “nice-to-have” data against site and patient burden — and, more importantly, patient safety.