Ames Study Manager
An integrated suite of software for conducting the Bacterial Reverse Mutation Test.
The Ames Study Manager is an integrated suite
of software for conducting the Bacterial Reverse Mutation Test according
to regulatory guidelines e.g. OECD 471, ICH S2A etc. It has been
designed to fulfil the requirements of safety assessment laboratories
in pharmaceutical, medical device and chemical companies as well
as contract research organisations.
Features of Ames Study Manager
- Accommodates any experimental design
- Versatile sharing of concurrent positive and negative controls
- Manual or automatic count entry
- Plates can be flagged for observations such as contamination,
precipitation etc
- Uses an Oracle relational database for complete security of
data and audit trails
- Seamless integration with Microsoft Word for generation of interim
and final reports
- Individually definable access rights for five different user
levels
- Complies with GLP guidelines & FDA 21 CFR Part 11 Final
Rule on Electronic Records & Electronic Signatures
Overview, Concept & Structure
At the outset it was clear that the Ames Study Manager should be
able to accommodate the varied methodologies
employed by different laboratories without compromising ease
of use. Furthermore, it needs to be capable of handling large
amounts of complex data. For these reasons, it was decided
to interface the program to an Oracle relational database for security
of data and audit trails.
This Study has a single Experiment with its one set of treatment
plates linked to one set of control plates.
» Show
diagram |
 This
diagram demonstrates sharing of Controls within Experiment Folders
for two concurrent Studies.
» Show
diagram |
 This
diagram demonstrates that experiments can share Controls on
a strain-by-strain basis.
» Show
diagram |
Conceptually, the program links a particular Test Substance
to one or more Studies. Each Study consists of one or an
extended series of Experiments. An Experiment consists
of the treatment plates for all of the strains used, doses, number
of replicates and metabolic activation.
The program is structured to allow concurrent
strain-specific positive and negative Controls with
or without metabolic activation to be shared between different experiments
whether they are part of the same or a different study. To achieve
this, the program groups together plates generated as controls for
a particular set of treatments into an Experiment Folder.
Each folder will contain plates which share a common incubation
time, method etc. In practice, an experiment folder is likely to
contain details of all experiment and control plates to be created
on a particular day.
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“I'm more and more impressed with this system the more I work on it.”
Study Director, global healthcare company, USA [More]
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E-mail: sales@perceptive.co.uk
