Prioritize QMS Process Automation or Risk Failure
A common pitfall in QMS process automation occurs with a poorly planned process [...]
17
04, 2017
3
04, 2017
FDA Warning Letters Emphasize Document Control System Compliance
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]
20
03, 2017
Avoid QMS Automation Failures with the Right Implementation Team
Even after decades of eQMS availability, a staggering number of projects still s [...]
14
03, 2017
Cybersecurity Management Expectations Clarified By FDA
The FDA has made it abundantly clear that it expects medical device manufacturer [...]
6
03, 2017
Increased QMS Compliance Inspections For International Life Science Manufacturers
International QMS compliance inspections of pharmaceutical and medical device ma [...]
20
02, 2017
Document Management + CGMP Compliance
Data integrity within your document management process is a critical component o [...]
14
02, 2017
Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Quality management efforts could be impacted by what appears to be an aggressive [...]
30
01, 2017
Risk Management Best Practices for Cybersecurity Compliance
A new FDA guidance concerning risk management helps medical device manufacturers [...]
23
01, 2017
Tougher Quality Management Enforcement By FDA In 2017
Quality management, always an FDA focus during inspections, could become even mo [...]
