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On 20 February, FDA withdrew all Part 11 Guides. The same is true of the
Compliance Policy Guide. The list of withdrawn documents is as follows:
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Guidance for industry, 21 CFR Part 11;
Electronic Records; Electronic Signatures Validation
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Guidance for industry, 21 CFR Part 11;
Electronic Records; Electronic Signatures,
Glossary of Terms
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Guidance for industry, 21 CFR Part 11;
Electronic Records; Electronic Signatures, Time Stamps
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Guidance for industry, 21 CFR Part 11;
Electronic Records; Electronic Signatures,
Maintenance of Electronic Records
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Compliance Policy Guide, CPG 7153.17:
Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic
Signatures;
Even on 4 February, FDA withdrew the guide
that had been published last, i.e. Guidance for industry, 21 CFR Part 11;
Electronic Records; Electronic Signatures, Electronic Copies of Electronic
Records 79" (see our GMP
News of 14 February).
What was withdrawn were the Part 11
Guides, not the Rule (i.e. 21 CFR Part 11) itself.
Of course, one wonders why FDA has taken
this quite radical step. What is sure is that the new cGMP Initiative has
triggered off this action (see our GMP
News of 4 September 2002). By means of this initiative, FDA intends to
adopt a risk-based approach to all regulatory and inspection requirements.
Apart from this, FDA sees 3 reasons that have led to the withdrawal. The
requirements mentioned in the Guides could bring about the following
negative effects:
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new electronic systems are introduced with a
delay or not introduced at all
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the firms have to carry disproportionately high costs due to the extensive
compliance measures
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innovative technologies are not introduced (without public health being
endangered by this)
FDA announces to exercise enforcement
discretion during inspections with regard to the requirements on
validation, audit trails, record retention, record copying and the requirements on legacy systems. This
"special handling" of the requirements will be practised until
the rule Part 11 has been re-evaluated/revised. FDA emphasises that all
other requirements have to be implemented as before. The text says:
It is important to note that FDA's exercise
of enforcement discretion as
described in this guidance is limited to the
specified part 11 requirements.
We intend to enforce all other provisions of
part 11 including, but not limited
to, certain controls for closed systems in
§ 11.10, the corresponding controls
for open systems (§ 11.30), and
requirements related to electronic signatures
(e.g., §§ 11.50, 11.70, 11.100, 11.200,
and 11.300). We expect continued
compliance with these provisions, and we
will continue to enforce them.
With the above-mentioned explanations for
the withdrawal of the different Part 11 Guides, a new Guide was published
containing FDA's current thinking on electronic records and electronic
signatures. It is titled: Part 11, Electronic Records;
Electronic Signatures – Scope and Application.
The text starts by giving the reasons for
the creation of this Guidance, the content being identical with what has
been said in the above-mentioned explanation in the Federal Register. The
actual content of the document takes up only 4 of the 9 text pages.
Already in the chapter "Narrow
Interpretation of Scope", the reader finds a far-reaching statement
on the handling of electronic records. Here, FDA says that, in case a
paper printout is maintained, it is not necessary any more to archive the
electronic record.
Point 2 "Definition of Part 11
Records" goes a bit more into the details of this item. FDA recommends
among others that one should pre-define which records will be maintained
in paper format and which ones in electronic format. This can best be done
in the form of an SOP.
In chapter C, FDA deals with those fields in
which they intend to exercise enforcement discretion. Here, the focus is
put especially on risk assessment. This key word is the central theme of the
Guidance. By means of a risk assessment one has to find out to what extent
a specific system can influence the product quality, safety, and record
integrity. If the result indicates a high risk, the requirements, e.g. on
validation, have to be implemented. If the risk proves to be low, this is
not necessary. In this context, FDA gives an example on which there have
been controversial discussions at numerous conferences at which FDA
officials were present. FDA says: For instance, a word processor used only to
generate SOPs would most likely not need to be validated. If one
develops this thought further, a text file containing an SOP (low risk for
product quality) would no longer have to be handled according to the Part
11 requirements either. But how is the situation for more complex records,
e.g. an excel sheet with calculations that are used for a release
decision? According to the approach described above, all of the
requirements of Part 11, i.e. validation, audit trail etc., would again
have to be observed.
In analogy to this, there is also a change
for audit trails. FDA recommends a risk-based approach here, too. At the
same time, FDA emphasises that:
Audit trails are particularly important
where the users are expected to create, modify, or delete regulated
records during normal operation.
Next to risk assessment, another point is of
importance: "All records held by you are subject
to inspection in accordance with predicate rules". For the decision
about the scope of measures to be implemented for certain electronic
records, it will therefore be crucial which requirements are defined in
the underlying GMP legislation (e.g. 21 CFR 210/211).
It will be interesting to know to what
extent FDA will change the rule Part 11, i.e. the law on which the
Guidances are based.
On the whole, one can say that FDA has made
concessions to many of the demands expressed by the industry. It may be
difficult to assess how far the enforcement discretion will go. In which
areas can one really ignore the requirements of Part 11? How can one
define that a specific record resulting from the GMP requirements
represents a comparably low risk for the product quality and is thus
exempted from the Part 11 requirements (also in case the record is created
and archived by means of an electronic system)?
You can download the new Draft via this link:
http://www.fda.gov/cber/gdlns/prt11elect.pdf
The following link leads you to the
announcement in the Federal Register (withdrawal of the Part 11
Guidances):
http://www.fda.gov/cder/gmp/cd0314.pdf
The following ECA events deal especially
with computer validation:
Author:
Oliver Schmidt
CONCEPT HEIDELBERG
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