International: +44 1440 730773Auditing, GLP and regulatory compliance
With powerful auditing features, forced entry of reasons for edits, deletes etc. and electronic signature options, Comet Assay IVTM satisfies the requirements of GLP and FDA 21 CFR part 11.
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 fields values. Users can also retrieve measurement and audit data and export it for use with the Spreadsheet Generator macro or other data processing and reporting tools.
User management options to fit your needs
The system as standard gives the ability for 2 accounts to be used; a supervisor account and a user account; the 2 accounts have their own separate passwords. The optional User Administration utility provides you with the ability to uniquely identify any number of 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 full compliance with the FDA 21 CFR part 11 final rule on electronic signatures and electronic records.
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 9001:2000 and TickIT testing procedures. All in-house project, test and validation documentation is made available to assist you with your own validation of the system.