Featured Articles

  1. 3 Ways To Improve QMS Documentation: Following International Standards 9/8/2022

    We share how to get the most out of documenting your quality management system that can also help you stick to ISO 9001 standards.

  2. 6 Best Practices For Enterprise Quality Management Solutions Implementation 9/8/2022

    While all enterprise software implementations are unique we share six best practices that will improve the likelihood of any successful quality management software implementation project.

  3. Why You Need A Document Management System In Life Sciences 8/25/2022

    In this blog we highlight the history and purpose of a document management system and look into the future with cloud-based electronic document software.

  4. 3 Biopharma Contract Manufacturing Trends You Must Know 8/18/2022

    Review three biopharma contract manufacturing trends that are indicators of exciting industry developments and also reveal areas that are ripe for change.

  5. 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.

  6. 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.

  7. 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. 

  8. 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. 

  9. 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.

  10. 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.