Integrated suite of software for managing and reporting the Ames test according to regulatory guideline is validated in accordance with ISO 9001:2000 and Tickit approved testing procedures
Perceptive Instruments says it has the solution to meeting all GLP guidelines and FDA 21 CFR Part 11 final rule on electronic records and electronic signatures for the Ames test.
It says the Ames Study Manager provides an efficient method for managing Ames tests including study design, data capture, storage and reporting.
The Ames test is used to determine the mutagenic potency of chemical substances which may be an indication of their carcinogenicity.
It is the most widely used safety assessment test and a requirement for FDA approval of many consumer and industrial products including chemicals, cosmetics, medical devices, household goods and food ingredients.
Pharmaceutical companies and contract research organisations particularly need to demonstrate strict compliance to GLP and FDA rules.
Ames Study Manager is an integrated suite of software from Perceptive Instruments for managing and reporting the Ames test according to regulatory guidelines.
It is validated in accordance with stringent ISO 9001:2000 and Tickit approved testing procedures.
It comes from a company claiming a long and successful track record in supplying colony counters and data processing for the Ames test.
The software is extremely versatile allowing it to fit in with different laboratory workflows and practices, it says.
Virtually any experimental design or protocol can be accommodated.
Individual plate counts are automatically captured by the program and stored securely in an Oracle database.
Detailed audit trails automatically record all activity including system settings, measurement parameters, data and full details of any changes made together with reasons.
Experiment, summary and audit reports are generated directly into Microsoft Word for easy integration with final study reports.
Perceptive Instruments has 15 years experience of offering comprehensive guidance and support through all stages of compliance to GLP and FDA environments.
Pre-installation guidelines, installation qualification documents and all project and test documentation are provided to assist with on-site validation and approval by QA and IT departments.
