Many [...] Read More
The FDA requires medical device manufacturers, pharmaceuticals manufacturers, biotech companies, biologic developers, and other FDA-regulated industries to comply with their regulations and implement controls.
These controls should also [...] Read More
Electronic record keeping is an essential yet complex part of running a life sciences firm. Modern software tools afford medical device manufacturers numerous methods for digitally tracking lots, batches and supply chain [...] Read More
Complying with Part 11 can be a difficult thing to do. This is in part due to the fact that FDA recalled all the guidances concerning the implement of Part 11 in September 2003. Companies have been left to their own means to interpret Part 11, since the FDA leaves the inspector’s interpretation to “his own discretion.”
Originally, the regulation was drafted and issued by the Agency at the request of the regulated industries. These industries [...] Read More