Regulatory compliant software for conducting and data managing the bacterial reverse mutation assay fulfils the requirements of safety assessment laboratories
The Ames Study Manager from Perceptive Instruments is now in routine use for both regulatory and high throughput screening Ames tests.
This integrated suite of software has been designed to fulfil the requirements of safety assessment laboratories in pharmaceutical, medical device and chemical companies as well as contract research organisations.
It was clear that the Ames Study Manager design needed to comply with the strict rulings applying to regulatory Ames (eg, GLPs and FDA 21 CFR Part 11), and accommodate the various methodologies employed by laboratories, without compromising on ease of use.
Consequently, the software allows concurrent, strain-specific positive and negative controls (solvent and untreated) with or without metabolic activation, to be shared between different studies and experiments.
Extensive use is made of templates to enable tests to be performed routinely, according to different experimental designs but which can be easily modified as necessary.
Colony counts are captured directly from the Sorcerer colony counter, or are entered manually.
During data entry and capture, prompts appear requiring mandatory reasons for any changes made, and the user is able to apply postfixes, eg P to indicate precipitation of the test compound.
All information gathered during the course of a study is sent directly to secure, independent database tables within Oracle.
Audit trail information is also held securely within Oracle tables.
The Ames Report Generator provides a choice of experiment report formats such as the OECD report that includes number, mean and standard deviation of revertant colonies for all strains, treatments and controls for +/-S9.
It also includes the ratio of treated and positive control plate counts to solvent control counts.
These are generated as customisable protected Microsoft Word documents.
A separate user administration program controls access to the Ames Study Manager using an Oracle database to securely hold all information relating to individual users.
Four configurable access levels are available: users, advanced users, study directors, and auditors.
Individual personnel are assigned specific login time-outs and password validity.
Companies are beginning to recognise the need for such powerful data management software, and Perceptive Instruments says that, as a result, Ames Study Manager is receiving increasing interest.
