Five Form Design Mistakes To Avoid When Automating Your QMS
Automated process management systems are the workhorses of every modern company. [...]
20
06, 2017
13
06, 2017
Medical Device Manufacturers Warned For CAPA Non-Compliance
Three recent warning letters from the Center for Device and Radiological Health [...]
30
05, 2017
FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus
After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batc [...]
17
04, 2017
Prioritize QMS Process Automation or Risk Failure
A common pitfall in QMS process automation occurs with a poorly planned process [...]
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 [...]
