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Life Sciences
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 [...]
How to Establish Sustainable Validation for FDA & EU Compliance
Software validation is historically one of the most difficult compliance activities for life sciences companies. It’s al [...]
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
As innovation in medical technology increases, potential cybersecurity threats also grow. The U.S. Food and Drug Adminis [...]
QMS Configuration vs. Out-of-the-Box: Real-World Considerations
When evaluating an automated QMS, the question to invest in configuration vs. out-of-the-box (OOTB) is a core functional [...]
EUDAMED Update: What You Need to Know Now
The European Union (EU) Medical Device Regulation (MDR) officially went into effect in May 2021, while the In-Vitro Devi [...]
AssurX Names Stephanie Ojeda as Director of Product Management for Life Sciences Industry
Morgan Hill, CA., June 22, 2022 — AssurX, Inc. (AssurX), a leader in quality management and regulatory compliance softwa [...]
