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Can Your Choice of Software Affect Your FDA Part 11 Compliance Efforts?

July 29th, 2014 by

Electronic Records[...] Read More

Getting Compliant With FDA 21 CFR Part 11

July 7th, 2014 by

FDA 21 CFR Part 11The FDA requires medical device manufacturers, pharmaceuticals manufacturers, biotech [...] Read More

Improve Record Keeping With 21 CFR Part 11

May 20th, 2014 by

Electronic SignatureElectronic record keeping [...] Read More

Why Is FDA 21 CFR Part 11 Compliance Important?

February 4th, 2014 by

Electronic RecordsComplying 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