AssurX Blog
Straight talk for regulated industries.
Medical Device Manufacturers Warned For CAPA Non-Compliance
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical device inspection investigative focus. CAPA non-compliance i [...]
Disciplined Patch Management is Essential: Take Note from the Energy Industry
The massive global cyber-attack on May 12 demonstrated a large lesson regarding disciplined patch management. The aggressive, insidious WannaCry ransomware impacted over 400,000 system [...]
FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus
After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batch of warning letters focused on pharmaceutical manufacturing quality issues in the first quarter of 2017 [...]
Strong Document Control Critical For NERC Compliance
Document control is invaluable to utilities trying to prevent or learn from system outages. Stakes are high. Consider the cost of outdated or insufficient documentation in terms of le [...]
How Will Real-World Evidence Impact 2017 FDA Guidances?
The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug Administration (FDA) to understand that medical device manufacturers want clarity on FDA's heightened foc [...]
CDRH Report: Quality Management Insights For Medical Device Manufacturers
FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives perta [...]
