Auditing and regulatory compliance

With optional user administration, powerful auditing and forced entry of reasons for edits, deletes etc., Comet Assay IV^TM 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

Secure system layout (click to enlarge)

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 Quality Management System which is approved to ISO 9001:2008 incorporating ISO 90003.

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 System Access Manager program provides those wishing to achieve compliance with FDA 21 CFR Part 11 the ability to uniquely identify users, define account rules and monitor system access. See the secure system layout diagram (above) for an illustration of how Comet Assay IV is commonly used within a regulatory environment.

Rescored audit image (click to enlarge)

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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