Validation, Commissioning & Design Featured Articles

  1. 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.

  2. 4 Conversations To Drive Your Business Case For Digital Validation 3/19/2025

    Change in life sciences is challenging due to strict regulations, high stakes, and the importance of patient safety. Learn how to advocate for digital validation workflows through four key conversations.

  3. What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025

    The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.

  4. Strengthening Shop-Floor QA From The Ground Up 2/24/2025

    Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.

  5. Asian Companies Leverage MES At Manufacturing Facilities 2/24/2025

    Asian pharma manufacturers are constantly under pressure to produce high quality products on time. Explore how Asian pharmaceutical companies are leveraging MES to enhance efficiency and compliance.

  6. The Impact Of The FDA's New CSA Draft Guideline 2/24/2025

    Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.

  7. Biopharma's Path To MES In The Cloud 2/24/2025

    The industry is shifting to cloud-based Manufacturing Execution Systems (MES). Discover how you can use a modern MES to enhance efficiency, collaboration, and compliance.

  8. Increasing Drug Manufacturing Efficiency With Intelligent Master Batch Record Design 2/24/2025

    Discover how to enhance your pharmaceutical production efficiency with an intelligent MBR design that offers tailored software, handling systems, and inspection machines.

  9. A Guide To The Ultimate Product Improvement Tool 2/18/2025

    Learn how to transform your product quality review that emphasizes systematic evaluation and improvement of product quality, highlighting automation benefits through modern software.

  10. Driving Continuous Improvement In The Digital Age 2/18/2025

    Discover the need for organizations to modernize Quality Management Reviews (QMR) through digital tools and analytics to enhance efficiency, collaboration, and continuous improvement.