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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
Five Form Design Mistakes To Avoid When Automating Your QMS
Automated process management systems are the workhorses of every modern company. These systems guide operations and impr [...]
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 medi [...]
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 aggres [...]
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 pharmace [...]
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 t [...]
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 m [...]
