Explore resources and examples that explain how small firms can perform monitoring procedures, document results, and turn SQMS No. 1 into an executable process. Firms will need to learn from mistakes, ...

Firms that perform audits, reviews, or compilations have a little more than four months to implement the new risk-based quality management (QM) standards. The task may feel daunting, but Joe Lynch, ...

With QMS/SCADA integration, operators can perform inspections within their SCADA interface, with automatic logging and immediate alerts when quality drift occurs. Unified platforms reduce licensing ...

Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for ...

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and ...