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Life Sciences
Linking Design Controls and Risk Management in the QMS
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administrati [...]
Complaint Management for Life Sciences with an Automated QMS
Effective complaint handling is fundamental to life sciences quality management, with implications for operations, prod [...]
AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)
AssurX will be exhibiting at this year’s ASQ World Conference on Quality & Improvement (WCQI). The conference will [...]
Update: EU Medical Device Regulation Deadlines Extended
European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) raises the bar for device safe [...]
Key Priorities for Proactive EHS Risk Management
In 2021, the U.S. Occupational Safety and Health Administration (OSHA) conducted over 24,000 inspections, most of them w [...]
FDA Warning Letters Show Document Management System Issues in Food Industry
Documentation is a subject that comes up frequently in U.S. Food and Drug Administration (FDA) warning letters and 483 o [...]
