Validation, Commissioning & Design Featured Articles

31. Struggling With GxP Systems? There's A DAP For That 4/2/2025

    A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

32. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

    The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

33. Embracing Turnkey And Outsourced Quality Management In Biopharma 3/28/2025

    In-house quality management systems often struggle to keep pace. Many organizations are adopting turnkey and outsourced quality management solutions to ensure compliance and enhance efficiency.

34. Water Activity: A Better Approach For Lyo Moisture Determination 3/24/2025

    Explore why residual moisture content is crucial for freeze-dried pharmaceuticals and how water activity measurement can enhance product safety and stability with innovative laser-based methods.

35. Digital Twins And Mechanistic Models For Optimized Bioprocessing 3/24/2025

    Integrating AI and having a robust IT infrastructure is crucial for modernizing your processes. Discover how digital twins and mechanistic modeling are revolutionizing biomanufacturing, enhancing efficiency, and reducing costs.

36. Upskilling Your Quality Team For The AI Revolution In Pharma 4.0 3/21/2025

    While AI systems offer advanced capabilities for data analysis, process optimization, and quality assessments, your quality team must first be proficient in interacting with them.

37. 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.

38. 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.

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 What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025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

40. 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.