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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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 [...]
7 Ways to Enhance Quality Management Training
In regulated environments, quality management training is a requirement for good reason. A workforce with proper traini [...]
