Featured Articles

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. Compliance Audits: 4 Solutions To Avoid Failure 9/20/2024

    Although inspection and audit processes have evolved, you can still effectively navigate and manage them within your organization. Explore four solutions to address audit and inspection pain points.

38. Simplify CAPA In 7 Steps 9/20/2024

    Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

39. CDMO Accelerates Contract Manufacturing With Electronic Batch Records 9/18/2024

    A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

40. Overcoming 3 Key Challenges Facing Life Science Contract Manufacturers 9/18/2024

    Explore the key challenges faced by CMOs and CDMOs in the life sciences industry and how digital transformation can help overcome them.