5 Building Blocks You Need for a Quality 4.0 Foundation
Market changes and disruptions such as the global pandemic are driving companies [...]
Understanding ALCOA+ Principles and Data Integrity for Pharma
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) curre [...]
Pharmaceutical Warning Letters Reveal CGMP Failures
Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. [...]
Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of [...]
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 [...]
How to Establish Sustainable Validation for FDA & EU Compliance
Software validation is historically one of the most difficult compliance activit [...]
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
As innovation in medical technology increases, potential cybersecurity threats a [...]
QMS Configuration vs. Out-of-the-Box: Real-World Considerations
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
EUDAMED Update: What You Need to Know Now
The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]
