Auditing
and regulatory compliance
With optional user administration, powerful auditing and
forced entry of reasons for edits, deletes etc., Comet Assay IVTM
satisfies the requirements of GLP and the FDA 21 CFR part 11 final
rule on electronic records and electronic signatures.
Meet regulatory requirements with Comet Assay IV
Comet Assay IV has a wide range of powerful
auditing and security features that can be implemented according
to your own requirements. The program generates in-depth
audit trails that include details of every action performed
by the users of the system, with date, time, system ID and a description
of the event. Audit trails record all original values along with
details of any edits or changes made.
Comet Assay IV has been designed and developed
with reference to a wide range of regulatory guidelines and is fully
compliant with the Good Laboratory Practice standards as set down
by the OECD, and has been comprehensively
tested and validated in accordance with our stringent ISO
9001:2000 and TickIT testing procedures
For the ultimate in system security, the software components of
Comet Assay IV can be run
entirely from secure remote network locations and has a range
of user account management options. The system is supplied with
our basic user administration package as which provides generic
logon acounts for each access level (user & supervisor). The
optional User Administration for Access utility
provides you with the ability to uniquely identify your users, whilst
those wishing to achieve compliance with the FDA 21 CFR Part 11
final rule on electronic records and electronic signature will want
the System Access Manager,
which provides powerful facilities for administering users and their
access levels. See the secure system layout diagram (above) for
an illustration of how Comet Assay IV is commonly
used within a regulatory environment.
The system can be configured to automatically save the video image
along with the measurement data whenever a cell is measured. These
images contain information including exact co-ordinates where the
user clicked to initiate the measurement and the results the measurement
produced. Upon retrieval of one of these images, it is possible
to re-measure the cell and, for the purpose of quality
assurance audits, compare the new data with the original.
Reason prompts can be used to show
a dialog to the user when they want to edit or delete a measurement
or clear unsaved data. Users can also be restricted from accessing
certain menu items or from using functions such as those for editing
or deleting measurements.
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study management | Advanced
user management >> |
