Regulatory Articles
-
The Dynamic Regulatory Environment Of Drug-Device Combination Products
11/29/2022
Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
-
Eliminating Data Integrity Errors Through Digitization
10/17/2022
Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.
-
Meta Biomed Accelerates Digital Transformation Improving Collaboration
9/29/2022
Learn how Meta Biomed implemented a solution to accelerate digital transformation, improve collaboration in a reliable, secure, and scalable cloud environment, and more.
-
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.
-
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.
-
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.
-
Steps To Successfully Complete An FDA Inspection
6/20/2022
We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.
-
How Early Raw Material Testing Mitigates Product Development & Regulatory Risk
6/7/2022
Materials not subjected to early testing can contain impurities/contaminants that impact downstream biocompatibility issues, which can increase the risk of regulatory hurdles.
-
Biological Indicators And The European Pharmacopoeia
5/10/2022
Here, we review the information concerning biological indicators in European Pharmacopoeia General Chapter 5.1.2, which is more detailed and covers a wider scope than the previous version.
-
The Search For Control: Total Quality In Life Sciences
2/18/2022
Bring data into one place to gain end-to-end visibility and traceability for total quality in every stage of research, development and manufacturing.