Effective reporting and management of historical control data for Ames assays

Historical control data plays a vital role in helping interpret the results of any Ames study. Such data is particularly useful for identifying trends over time, such as marginal but definite increases in reverse mutations. The OECD 471 guideline on the Ames bacterial reverse mutation assay states that laboratories are required to submit historical control data as part of the findings of a regulatory study.

Collating historical control data manually is both time-consuming and prone to error. By centralising all Ames data within a secure, trusted database system such as Oracle, collecting statistics and drawing graphs from historical control data can be automated and controlled in a manner conducive with the principles of GLP and the FDA 21 CFR part 11 final rule on electronic records and electronic signatures.

Whilst some laboratories include the very latest control data within each new study report, others will update their statistics on a monthly or yearly basis. Whichever method is used, the program ensures that data is kept safe and secure. Because GLP compliance is of utmost importance to those performing regulatory Ames assays, the system provides full audit trails, hierarchical permissions-based access and GLP reason prompts for any changes made. When used in conjunction with the System Access Manager for user account management, the system is fully compliant with the FDA 21 CFR part 11 final rule on electronic records and electronic signatures.

For further information, contact Perceptive Instruments:
Telephone: +44 1440 730773
Email: sales@perceptive.co.uk
Internet: http://www.perceptive.co.uk