Understanding ALCOA+ Principles and Data Integrity for Pharma
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) curre [...]
22
09, 2022
7
04, 2022
FDA Warning Letters Highlight Food Safety Compliance Issues
The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters [...]
24
03, 2022
5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process
This article is part two of a two-part series focused on GMP quality audit manag [...]
23
09, 2021
New FDA Traceability Rules Coming: What the Food & Beverage Industry Needs to Know
In FDA-regulated industries, a single event can lead to widespread change. For e [...]
4
08, 2020
Why Consider a Cloud QMS for FRACAS Automation?
Authors: Sal DiIorio, Principal Consultant, Semi-Tech Group Dave Vadas, VP of Sp [...]
14
05, 2020
Effectively Managing Data Integrity for CGMP
Data integrity is a key component in making informed decisions within any organi [...]
7
02, 2018
2017 Recap: FDA Warning Letter Observations and Trends
In 2017, the FDA released 476 warning letters. Top FDA warning letter violations [...]
15
08, 2017
FDA Warning Letters: First Half of 2017 Trends
The FDA released 225 warning letters in the first half of the year. AssurX, a QM [...]
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 [...]
