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5 Strategies to Improve Quality Incident Management and Root Cause Analysis
Imagine you’re doing a pre-shipment inspection on multiple pallets containing product canisters. As a result of the insp [...]
AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables
RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality management and regulatory compliance systems [...]
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) r [...]
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 [...]
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 [...]
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. [...]
