Source: http://www.validation-online.net/FDA_COMPLIANT-VALIDATION_105.html
Timestamp: 2017-03-30 00:49:41
Document Index: 625419646

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art\n11']

21 CFR Part 11 Guidance Document.
Part 11 latest guidance
now appears that the current
FDA Guidance rules pertaining to 21 CFR Part 11 may be with us for a
time than was originally anticipated. So
we have incorporated the guidance suggestions in this guidance
document, into
our current Validation Risk Assessment (now issue 10), which is now
Part 11 will be interpreted narrowly; we are now
clarifying that fewer
records will be considered subject to part 11.
would appear to mean that the
original all embracing approach to all electronic records is to be
dropped and
the rigors of part 11 applied only to the data that directly affects
quality and safety, and record (of the product) integrity.
For those records that are to remain the subject of
part 11, we will
apply discretion in the validation of audit trails, record retention,
record copying.
This would appear to mean that if
in-house document control is secure and robust; then it will be
acceptable in
the matter of audit trail / record retention and record copying. We will enforce all predicate rule requirements,
including predicate
rule record and recordkeeping requirements.
a statement to the effect that
in all other ways 21 CFR Part 11 will be enforced.
Accordingly, we recommend that, for each record
maintained under predicate rules, you determine in advance whether you
rely on the electronic record or paper record to perform regulated
We recommend that you document this decision (e.g., in a Standard
Procedure (SOP), or specification document).
requirement for a database of predicate (all) data records, giving a
and approved justification for the method of storage. Basically number:
1. It is not a predicate data.
2. It is predicate data, but does not
require to be stored in compliance with Part 11. 3. It is predicate data that must be
stored in compliance with current Part 11 requirements.
A predicate data record does not require to be Part
11 compliant;
unless it is the master copy of the predicate data and is stored in an
electronic format. I.E. if
the record is derived from an
electronic source and is downloaded into a hard copy format; which then
your master copy of the record; then this paper copy is not subject to
requirements; but must comply with all the other rules and regulations
governing the management of predicate data records.
Click here if you wish to read the whole guidance document.
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