Automated process management systems are the workhorses of every modern company. These systems guide operations and improve quality and efficiency. Hidden away in the core of each automated [...]
In Warning Letters/Recalls, Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance ManagementPosted
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 is a top [...]
By Dave Vadas
In Electric Reliability, FDA Regulated, Security, FDA Regulated Industries, Regulatory Compliance ManagementPosted
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 systems in more [...]
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