In
Volume 67, Number 172 of the Federal Register FDA has announced the
"Draft Guidance for
Industry,
Electronic Records; Electronic Signatures, Maintenance of Electronic
Records". In the preamble to the requirements 21 CFR
Part
11 "Electronic Records; Electronic Signatures" published on March
20, 1997 additional guidances for purposes of concretisation and
interpretation were announced. The Draft Guidance
now
published supplements the only recently published guidances on
Validation, Time Stamps and Glossary of Terms. The deadline for
commentaries lasts until December 4 of this year.
The
document comprises 27 pages. It
deals with the maintenance and availability of electronic records during
the retention period. Section
11.10 (c) of 21 CFR Part 11 stipulates that it is necessary to establish
the following aspects: "procedures and controls for the protection
of records to enable their accurate and ready retrieval
throughout the records retention period You should update the procedures
and controls as conditions warrant."
The
procedures/instructions should, for instance, regulate the following
items:
- How
are the electronic records stored?
- What
storage conditions exist and what safety measures are taken?
Section
5.3 of the new Draft Guidance reads that a representative number of
electronic records must be read in at regular intervals in order to
check whether these electronic records can still be read in.
Furthermore, it reads that any "difficulties" observed during these
checks while reading in the electronic records these should be migrated
into the new electronic records.
The
ambient conditions in which the electronic records are retained must
also be permanently monitored. These are temperature, humidity as well
as electromagnetic interference. Additional interesting comments can be
found in the following as to what measures must be taken for the
maintenance of electronic records. Special attention is drawn to the
making of copies and the fact that all functionalities existing in an
electronic record must continue to be available throughout the entire
retention period.
Of
particular interest are the two approaches to maintaining the
availability of electronic records mentioned in Section 6. The first
approach, the "Time capsule approach" assumes that the necessary
hardware and software will also be retained throughout the retention
period. These may not be modified in any way, i.e. for instance no
updates may be performed on them. This approach - and the Guidance
itself admits this - will tend to be the exception in view of today's
technical progress. Applications can be seen above all where very short
retention periods are involved.
The
second approach, the "Electronic Record Migration Approach" will
probably represent the most frequent case. Here the demands placed on
the migration of data and metadata are very high. The present Guidance
defines therefore in detail what measures are to be taken in case of
migration. Here the migration process, e.g. also the Audit Trail
Information must be transferred and the information of the Audit Trail
must be supplemented by the information on the migration process itself.
The problem of an electronic signature being connected with an
electronic record is also dealt with. The migration process must take
place with the involvement of a "trusted third party".
The
European Compliance Academy (ECA) is organising in cooperation with
Concept Heidelberg on December 2-3, 2002 in Barcelona the event GMP-/FDA-Compliant
Raw Data Management and Archiving. Here the retention of raw
data and metadata as well as data migration, data authenticity and data
integrity will be discussed.
For
the interpretation of Rule 21 CFR Part 11 and of the individual
guidances we are also organizing in 2002
Author:
Oliver Schmidt, CONCEPT HEIDELBERG
You
can download the commentated draft here:
http://www.fda.gov/cber/gdlns/esigmaint.pdf
