CDRH Report: Quality Management Insights For Medical Device Manufacturers
FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self- [...]
8
05, 2017
17
04, 2017
Prioritize QMS Process Automation or Risk Failure
A common pitfall in QMS process automation occurs with a poorly planned process [...]
11
04, 2017
Successful QMS Implementation Requires Clearly Defined Processes
Industry-leading quality management systems (QMS) are built with clearly defined [...]
10
04, 2017
China Addresses Life Sciences Regulatory Compliance Concerns
China has often faced criticism for lax regulation of drug and medical device ma [...]
3
04, 2017
FDA Warning Letters Emphasize Document Control System Compliance
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]
28
03, 2017
FDA States Clear cGMP Expectations for Combination Products
The Food and Drug Administration (FDA) recently released a final guidance on Cur [...]
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 [...]
