Why Change Control is Important: Tips for Manufacturers
Change is a constant in manufacturing, and is both necessary for innovation and [...]
22
02, 2024
22
09, 2022
Understanding ALCOA+ Principles and Data Integrity for Pharma
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) curre [...]
15
09, 2022
Pharmaceutical Warning Letters Reveal CGMP Failures
Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. [...]
1
09, 2022
Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]
25
08, 2022
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of [...]
3
08, 2022
Supply Chain Traceability and The FDA Blueprint for Smarter Food Safety
From Listeria in ice cream to E. coli in lettuce, there’s one central question i [...]
26
07, 2022
How to Establish Sustainable Validation for FDA & EU Compliance
Software validation is historically one of the most difficult compliance activit [...]
20
07, 2022
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
As innovation in medical technology increases, potential cybersecurity threats a [...]
13
07, 2022
QMS Configuration vs. Out-of-the-Box: Real-World Considerations
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
30
06, 2022
EUDAMED Update: What You Need to Know Now
The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]
