Featured Articles

31. 6 Must-Haves For A Quality Management System (QMS) 9/20/2024

    Not every quality management system (QMS) has the same capabilities and connectivity. Review several features to take into consideration when selecting a QMS system for your organization.

32. How Generative AI Streamlines GxP Compliance In Life Sciences 9/20/2024

    Generative AI is reaching a critical juncture in the life sciences industry. Learn how it is changing the game for GxP Compliance and enabling organizations to improve operational efficiency.

33. The Importance Of Vendor And Supplier Quality Management 9/20/2024

    Explore the importance of supplier quality management, relevant standards, regulatory audits, best practices, and the overall significance of this practice within the life sciences sector.

34. 3 Tips For An Effective Medical Device Risk Analysis 9/20/2024

    For risk analysis to be successful, it must be carried out comprehensively from beginning to end. A holistic, integrated approach is essential, along with the adoption of appropriate tools.

35. EU To U.S. Market: Understanding 3 Core Regulatory Contrasts 9/20/2024

    Learn about three key regulatory differences between the United States and the European Union that can significantly impact the success of your market entry.

36. A Modern Pharma MES Solution Offers The Best Of Old And New 9/20/2024

    What do legacy manufacturing execution systems (MESs) lack? What can a modern pharma MES solution do? Explore the advantages of using a modern MES to evaluate the efficiency of your production line.

37. 5 Key Elements Of Quality By Design In Pharma 9/20/2024

    Learn about the advantages of embedding quality throughout design and manufacturing, explore five practical elements of QbD in pharmaceuticals, and discover how a QMS can support QbD.

38. Deviation And Change Control In Pharmaceutical Manufacturing 9/20/2024

    Explore deviation management and change control in the pharmaceutical industry, the elements of Corrective and Preventive Action (CAPA), and how to best approach these three interconnected processes.

39. Quality Agreements With Contract Manufacturing Organizations (CMOs) 9/20/2024

    Explore seven essential details you should include when creating an effective contract manufacturing organization (CMO) quality agreement.

40. How To Get Ready For 21 CFR Part 820/ISO 13485 Harmonization 9/20/2024

    Explore the key aspects of the harmonization between 21 CFR Part 820 and ISO13485 and guidance regarding how to ensure compliance with the new Quality Management System Regulation (QMSR) standards.