3Analytics Partners With AssurX to Revolutionize IMDRF Coding Using AI
The IMDRF Coding solution integrates seamlessly into AssurX EQMS, ensuring comp [...]
The IMDRF Coding solution integrates seamlessly into AssurX EQMS, ensuring comp [...]
SAN FRANCISCO, Jan. 15, 2025 – BPM LLP, one of the 35 largest public accounting [...]
Risk mitigation is crucial for manufacturing quality products because it helps [...]
FDA inspections and subsequent actions all come down to product quality. Qualit [...]
In FY 2023, the majority of warning letters issued to pharmaceutical manufactur [...]
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) curre [...]
The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters [...]
This article is part two of a two-part series focused on GMP quality audit manag [...]
In FDA-regulated industries, a single event can lead to widespread change. For e [...]
Authors: Sal DiIorio, Principal Consultant, Semi-Tech Group Dave Vadas, VP of Sp [...]