Featured Articles

31. 6 Common Myths About Adopting A Manufacturing Execution System (MES) 8/18/2022

    For manufacturing organizations that haven’t fully digitized their production processes because of the high cost and complexity of conventional MES solutions, it’s time to put those fears to rest. This industry brief explores and dispels six common misconceptions of adopting MES in life sciences manufacturing.

32. A Guide To Writing Effective SOPs In Life Sciences 8/17/2022

    We share some SOP guidelines that can help you build and manage documents that are easily accessible, relevant, and something your team can consistently rely upon.

33. 8 Tips to Make Computer Software Validation (CSV) Less Painful 7/21/2022

    While CSV can be a pain to deal with, it is necessary. Explore our eight best practices that can reduce validation time to a matter of hours or minutes.

34. The Role Of FDA Predicate Rules In 21 CFR Part 11 Compliance 7/8/2022

    Explore the relationship between FDA predicate rules and GMP, GLP, GCP, or other requirements applicable to your organization. 

35. 8 Best Practices For Compliant And Quick Software Validation In The Cloud 7/6/2022

    Learn how to significantly lighten the software validation load for your cloud environment system with these eight key practices. 

36. The Future Of The FDA: Operating In An “Electronic World” 7/6/2022

    Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.

37. 10 Things To Know Before Writing An FDA 483 Response Letter 7/6/2022

    Learn why time is of the essence when crafting a FDA response letter and remediation plan as well as the best practices for responding.

38. What CDMO's Should Know About Digitization 6/24/2022

    Explore how embracing digitization in manufacturing can help CMOs and CDMOs improve the efficiency of their operation and attract company partnerships. 

39. The 4 Phases Of CAPA Maturity: A Guide To Mastering Quality Event Management 6/22/2022

    This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help optimized strategies.

40. The No. 1 Most Common Problem In FDA GMP Inspections 6/20/2022

    With issues involving quality responsibilities and procedures at the top of the FDA warning list, we uncover where the solution to make this problem a thing of the past.