AssurX Blog
Straight talk for regulated industries.
Understanding ALCOA+ Principles and Data Integrity for Pharma
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) current good manufacturing practices (cGMP) regulations. Pharmaceutical manufacturers must ensure data is rel [...]
Pharmaceutical Warning Letters Reveal CGMP Failures
Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. However, it’s an area where many pharma manufacturers still struggle. In fact, 30 percent of FDA pharma [...]
Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assessments (RRA). The FDA wants to expand RRA across all product areas to supplement in-person inspections af [...]
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of EU MDR & IVDR regulation challenges. According to a 2022 Medical Device Coordination Group (MDCG) po [...]
Overcoming Common Challenges of Customer Quality Complaint Handling
From food and beverage to electronics to CPG, there’s not a single type of manufacturer that’s immune to customer complaints. While customer complaints are never something an organizat [...]
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 in any foodborne illness outbreak: where did the contamination happen? It’s a simple question with often [...]
