Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]
SOP in QMS
Mistakes around standard operating procedure (SOP) management are widespread an [...]
Linking Design Controls and Risk Management in the QMS
Design controls are a frequent citation in 483 observations and warning letters [...]
Complaint Management for Life Sciences with an Automated QMS
Effective complaint handling is fundamental to life sciences quality management [...]
AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)
AssurX will be exhibiting at this year’s ASQ World Conference on Quality & [...]
Remote Quality Audits for Regulated Companies Come of Age
This article is part one of a two-part series focused on GMP quality audit mana [...]
Trend Watch: 2022 and Beyond Will see Maturation of Internal Control Programs
Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Int [...]
