AssurX Blog
Straight talk for regulated industries.
Cybersecurity Management Expectations Clarified By FDA
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t a [...]
Increased QMS Compliance Inspections For International Life Science Manufacturers
International QMS compliance inspections of pharmaceutical and medical device manufacturers by the FDA and MHRA are on the rise. FDA & MHRA Increase Inspections Both the Food and D [...]
NERC Outlines Top 9 Risks to Bulk Power System
The North American Electric Reliability Corporation (NERC) releases report sharing insights and tips to help utility industry professionals identify, prevent or at least mitigate thre [...]
Document Management + CGMP Compliance
Data integrity within your document management process is a critical component of both Current Good Manufacturing Practice (CGMP) compliance as well as a strong quality management syst [...]
Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Quality management efforts could be impacted by what appears to be an aggressive guidance agenda for 2017 from the Center For Drug Evaluation and Research (CDER). Former FDA Chairman R [...]
NERC CIP Cybersecurity Risk Management: Being Proactive in 2017
NERC CIP cybersecurity risk management efforts by savvy utility grid operators have taken on a renewed focus in 2017 in response to increased cybersecurity threats. Proactive Cybersecu [...]
