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Update Feb 26, 03
Part 11 – The FDA issues a new Compliance Guidance Document
The today issued a new Guidance Document for how they intend for companies
to comply with Part 11 – Electronic Records.
If you were not aware, the FDA has been regulating Electronic Documents
since 1997, though only recently enforcing their compliance.
Over the past few years the FDA has taken it’s experience in inspecting
companies for Part 11 compliance and have issued this new Guidance. Please
be aware that this is a Draft Document and is not for implementation. The
FDA is asking for comments on this document at this time.
There are some very interesting changes to how the FDA will expect companies
to comply with this regulation.
One of these changes that pops out of this new document, is that the FDA has
changed its interpretation of the Scope of Part 11. The guidance document
goes on to state:
“xxxSome have understood the scope of part 11 to be very broad. We believe
that some of those broad interpretations could lead to unnecessary controls
and costs and could discourage innovation and technological advances without
providing added benefit to the public health. As a result, we want to
clarify that the Agency intends to interpret the scope of Part 11 narrowly.”
It goes on to state:
“Under the narrow interpretation of the scope of Part 11, with respect to
records required to be maintained or submitted, when persons choose to use
records in electronic format in place of paper format, Part 11 would apply.
On the other hand, when persons use computers to generate paper printouts of
electronic records, those paper records meet all the requirements of the
applicable predicate rules, and persons rely on the paper records to perform
their regulated activities, the merely incidental use of computers in those
instances would not trigger Part 11. xxx. (This is critical for all
companies to understand when the FDA is conducting their inspections.)
xxxIn such instances, FDA would generally not consider persons to be “using
electronic records in lieu of paper records” under sec. 11.2(a) and
11.2(b).xxx
This Guidance Document will clarify many of the Part 11 issues that have had
the industry confused as well as the FDA investigators.
For a copy of the Guidance document please go to the following link:
http://www.fda.gov/cder/guidance/5505dft.PDF
or contact mdi directly at – info@mdiconsultants.com and put Part 11
guidance in the subject.
If you have any questions on this document please contact mdi
U.S. AGENT
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