ABSTRACT
Part 11 was first introduced in 1997 and is part of FDA’s attempt to modernize the regulation and compliance
of industries under their auspices. It is widely viewed by FDA as an opportunity for industry to improve business processes as opposed to just another regulatory burden. In February 2003 FDA issued its current thinking on the topic and withdrew the draft guidance for industry, 21 CFR Part 11, because it wanted to avoid loss of time spent by industry in an effort to review and comment on the draft guidance when that guidance may no longer be representative of FDA’s approach under the new current good manufacturing practice (CGMP) initiative.
