Auditing, GLP and regulatory compliance

With powerful auditing features, forced entry of reasons for edits, deletes etc. and electronic signature options, Comet Assay IV^TM satisfies the requirements of GLP and FDA 21 CFR part 11.

Rescored audit image

Comprehensive audit trails

Comet Assay IV has a wide range of powerful auditing and security features that are included as standard with the system. The program generates in-depth audit trails that include details of every action performed by the users of the system. The system can be configured so users must give reasons for actions such as editing or deleting measurements.

Comet Assay IV automatically saves images along with measurement data whenever a cell is measured. 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.

Secure database transfer

As well as saving to protected Excel workbooks, Comet Assay IV also offers the ability to connect to an Oracle database for secure storage of all measurement and audit data.

The optional Data Extractor utility gives authorised users the ability to browse all data within the database and includes facilities to group or filter data on any combination of field values. The Data Extractor also allows users to approve, reject and archive data in accordance with OECD guidelines.

Users can export study data Excel, XML and encrypted formats. This allows for ultimate portability, integration into existing data management system and security of data.

User management options to fit your needs

The system as standard gives the ability for two accounts to be used: a supervisor account and a user account. The optional System Access Manager utility provides full compliance with the FDA 21 CFR Part 11 final rule on electronic records and electronic signature and allows you to uniquely identify and audit any number of users.

Validated and used by the world's leading labs

Comet Assay IV has been validated to produce excellent, highly reliable accurate results at several of the world's leading testing genotoxicity laboratories. Guidance is given through all stages of the validation process and we help by providing Installation Qualification documents, pre-installation guidelines and any other relevant documentation prior to the installation.

The program has also been comprehensively tested and validated in-house in accordance with our stringent ISO 9001:2008 approved testing procedures. All in-house project, test and validation documentation is made available to assist you with your own validation of the system.