Featured Articles

  1. How Process Digitization Accelerates Northeast Scientific's FDA Compliance 9/20/2022

    Learn how Northeast Scientific digitized and integrated our quality and manufacturing processes to help obtain 510(k) clearance from the FDA for the first and only reprocessed laser atherectomy catheter in the history of reprocessing.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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. 

  9. 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. 

  10. 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.