FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus
After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batc [...]
30
05, 2017
23
05, 2017
Strong Document Control Critical For NERC Compliance
Document control is invaluable to utilities trying to prevent or learn from syst [...]
16
05, 2017
How Will Real-World Evidence Impact 2017 FDA Guidances?
The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug Ad [...]
3
05, 2017
Cloud Computing Impact in the Energy and Utilities Sector
Technology-averse energy & utilities companies are about to embrace the powe [...]
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 [...]
