Can Your Choice of Software Affect Your FDA Part 11 Compliance Efforts?
July 29th, 2014 by Zuhdi HusseinGetting Compliant With FDA 21 CFR Part 11
July 7th, 2014 by James FrancumThe FDA requires medical device manufacturers, pharmaceuticals manufacturers, [...] Read More
Improve Record Keeping With 21 CFR Part 11
May 20th, 2014 by James FrancumElectronic record [...] Read More
Why Is FDA 21 CFR Part 11 Compliance Important?
February 4th, 2014 by James FrancumComplying 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 [...] Read More