Opinion: 3 Reasons to Consider SaaS for Quality Management Software
If you've been thinking about Software as a Service (SaaS) for your QMS and tryi [...]
14
03, 2018
16
01, 2018
How to Leverage an eQMS for Managing Product Adulteration
Recent FDA warning letters indicate that many drug manufacturers do not have man [...]
24
10, 2017
Cybersecurity Preparedness, Equifax, and Ben Franklin
Cybersecurity Preparedness: The prudent advice Benjamin Franklin shared with the [...]
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 [...]
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 [...]
