Auditing, GLP and regulatory compliance
Validated at sites worldwide
Comet Assay IV is used across the globe in many contract research and pharmaceutical environments where the need for a GLP-compliant system with robust auditing features is essential.
Comprehensive audit trails
Comet Assay IV has a wide range of powerful auditing and security features that are included as standard with the system:
- generate in-depth audit trails that include details of every action performed by the users of the system.
- forced user-defined reasons for actions, such as editing or deleting measurements.
- automatically saves images along with measurement data whenever a cell is measured.
- re-measure the comet from saved images.
- perform quality assurance audits by comparing new data with historical.
To improve data security and regulatory compliance, we offer additional software programs and features which can be added to any Comet Assay IV package. Find out more about these packages and read more on the optional Data Extractor and System Access Manager programs below:
Secure data transfer with Data Extractor
Automatically, Comet Assay IV will save data to protected Excel workbooks, however, you may wish to upgrade you Comet Assay IV system to connect to an Oracle database for secure storage of all measurement and audit data.
The Data Extractor utility gives:
- extra data security using an Oracle database
- authorised users can have the ability to browse all data within the database.
- facilities to group, or filter, data on any combination of field values.
- the ability to approve, reject and archive data in accordance with OECD guidelines.
- export study data in Excel, XML and encrypted formats.
Data extractor allows for the ultimate portability and security of data. The integration of data into an existing data management system is easy and safe with Data Extractor.
Bespoke user management options with System Access Manager
The Comet Assay IV system comes as standard with two accounts: a supervisor and a user. However, to achieve full compliance with the 21 CFR Part 11 rules, System Access Manager can be added to a system.
The System Access Manager utility provides:
- full compliance with the FDA 21 CFR Part 11 final rule on electronic records and electronic signatures.
- unique identification of each user.
- the ability to add any number of users.
- detailed person-specific audit trails.
Validation by global leading laboratories
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 (IQ) documents, pre-installation guidelines and any other relevant documentation prior to the installation.
Quality assurance
Comet Assay IV has also been comprehensively tested and validated in-house by Perceptive Instruments Ltd. 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.