September 19, 2024
How To Apply Statistical Techniques In A Quality Management System (QMS)
21 CFR 820, Subpart O, the last subpart of the Quality System [...]
Author: Michelle Bonn
Michelle leads Compliance Team's strategic direction and vision. She ensures the team is executing on corporate sales, operational improvements, and expanding service offerings.
September 5, 2024
5 Best Practices For Supply Chain Risk Management
Supply chains are ever-increasing in complexity. Supply chains [...]
August 8, 2024
Top 8 Medical Device Cybersecurity Documents A Manufacturer Should Follow
Medical devices are becoming increasingly interconnected, so they [...]
June 27, 2024
GMP Biologics Manufacturing: The Ultimate Guide To Compliance
Good Manufacturing Practices, or GMP, is a set of guidelines and [...]
May 19, 2024
What Is A User Requirements Specification [URS]?
By clearly defining user requirements in the user requirement [...]
May 9, 2024
Most Popular FDA 483 Observations: 2024 Edition
For companies operating in industries regulated by the Food and [...]
April 25, 2024
Case Study: Mastering Manufacturing Compliance
About The Client Compliance Team worked with a manufacturer of [...]
October 12, 2023
Life Science Mergers & Acquisitions – Performing Effective Due Diligence
When companies are acquired or merge, inherent risk is [...]
September 26, 2023
What Are The Requirements For A Cyber Device In The Medical Industry?
In a previous article, I explained that cybersecurity attacks in [...]