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Ames Study Manager

Plate counting, data management and reporting for the ames test.

  • Accommodates any experimental design
  • Versatile sharing of concurrent controls
  • Instant capture of automatic plate counts
  • Plate observations for contamination, precipitation etc.
  • Integration with Microsoft Word for customisable reporting
  • Complies with GLP and FDA 21 CFR Part 11
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Overview

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 S2(R1) etc.

Ames Study Manager is found in laboratories across the globe and has an excellent reputation for increasing productivity whilst improving compliance with GLP regulations and requirements.

Testimonials

“We have been working with the Sorcerer Colony Counter and Ames Study Manager software that you provided us, and we never have problems with it. The results that we obtain with it are very good for our customers.”

Study Director, Contract Research Organisation, Europe

Screenshots

How it works

Flexible study management

Each study created with Ames Study Manager can have any number of individual experiments, each unique in design. Designs can be saved as templates for future studies. The program is structured to allow control plates to be shared by multiple experiments. To achieve this level of flexibility, the program makes use of ‘experiment folders’. All plates within an experiment folder share the same incubation time and assay conditions, and as such can be considered suitable for sharing.

Automatic plate counting

Automatic plate counts are retrieved instantly from Sorcerer Colony Counter. Users simply select the plate they wish to count and press the space bar. There are also facilities to use barcode readers, or to allow manual counts to be entered, with configurable GLP enforced reasons for actions such as recounting a plate.

Data security

All data is secure within Ames Study Manager. Our user access management program, System Access Manager, is used in environments  compliant with the FDA 21 CFR Part 11 Final rule on Electronic Records & Electronic Signatures. In addition, you can assign different access rights within Ames Study manager to different users. Data can be locked to avoid accidental deletion or editing.

Reporting

As well as automatically generating data tables and study reports, custom reports can be created for plate preparation, auditing or anything else you need. These reports can be password protected for extra data security.

Historical data & archiving features

To complete your Ames Study Manager package, you can add the following optional modules: Ames Historical Controls and Ames Archive Manager.

Reasons to buy

Used by the experts

Validated by labs worldwide, Ames Study Manager is used by the vast majority of the world’s leading pharmaceutical and contract research organisations. The system has been designed in line with OECD 471, so the workflow will be familiar to your users from the start. Ames Study Manager can accommodate any study design, and reporting is completely customisable so reports can be tailored to match your organisation’s approach.

Faster study turnaround

An automatic plate counter gives you immediate results that you can rely on. Study templates allow you to save frequently-used study designs so you don’t need to worry about re-configuring, re-typing or re-entering setup information. Data collection is integrated with the system and as soon as data is collected, it can be reported. There are no transcription steps or file transfers. Reports are created automatically and can include data tables, graphs and statistics. Historical control ranges are created automatically in seconds.

Increase traceability of data

Ames Study Manager has been designed with reference to the OECD and S2(R1) guidelines. It is fully compliant with the principles of Good Laboratory Practise (GLP) and the FDA 21 CFR part 11 rule on electronic signatures.
All actions which are carried out within Ames Study Manager, such as creating, editing and deleting data, are recorded within an audit trail. Original data are never obscured; where a data change is made, the old and new values are visible along with any reasons given for the change.

Supported by the experts

When you purchase Ames Study Manager, you will receive a comprehensive support package including software updates and unlimited support over phone, email and via screen sharing tools. We will install your system and provide training, report customisation and validation assistance to ensure that you get the best from Ames Study Manager.

Regulatory compliance

You work to GLP, and so does Ames Study Manager.

Ames Study Manager has been designed with reference to the OECD and S2(R1) guidelines. It is fully compliant with the principles of Good Laboratory Practise (GLP) and the FDA 21 CFR part 11 rule on electronic signatures. Modules are available for reporting historical control data and for archiving completed studies in accordance with OECD guidelines.

Comprehensive auditing

Ames Study Manager includes a comprehensive and clear audit trail. All actions which are carried out within the Ames Study Manager, such as designing a study layout or creating, editing and deleting data, are recorded within the audit trail. Every auditable event can be used to force a user into giving a reason for a change (e.g. when re-counting a plate), or to force the user to re-input their passwords to confirm their identity. Authorised users can use the audit viewer to review actions such as creations, modifications or deletions, and then generate reports.

Validation assistance

We are on hand to help with all your regulatory compliance documentation needs. For your assistance, we will provide all of our own project, testing and validation documentation along with IQ documents and training certificates.

Controlled user access

Within the Ames Study Manager, every user can be assigned to a specific set of access rights and permissions. This means that actions such as viewing, editing and creating items within the Ames Study Manager can be locked away from certain users. For example, you can:

  • allow study directors to see all information relating to a study, add annotations and electronic signatures as they wish
  • allow scorers to be able to collect data within the Plate Editor counting screen, but prevent them from modifying study setups
  • allow quality assurance staff to review studies without being able to edit, create or delete data

Technical specification

Plate counting

Counts can be captured directly from automatic colony counting systems such as Sorcerer. Optional manual entry of count data via Plate Editor utility.

Study scope

No constraints for numbers of Studies, Experiment Folders, Experiments, Test substances, Strains, Control sets, Positive control chemicals etc.

Study details

Name, Start Date, Study Type, Test Substance, Description, Client, Study Director. Any number of additional fields configurable. Can be configured as compulsory or optional entries.

Experiment scope

Each subset of plates within an experiment may be configured differently for dose levels, strains, number of plates, metabolic activation etc.

Experiment details

Name, Start Date, Type, Description, Solvent, Justification for solvent used, Solubility. Any number of additional fields configurable. Can be configured as compulsory or optional entries.

Test substances

Name, CAS No., Reference No., Batch, Origin, Physical Nature, Properties, Stability, Storage Conditions.

Plate groups

Test substance, Solvent control, Untreated control, Viability, Positive control (1 or 2 sets).

Plate postfixes

Unlimited number of plate postfix codes for observations such as Incomplete lawn, Precipitation etc. Can be applied to single or multiple plates.

Positive controls

Control code, Date created, CAS No., Reference No, Manufacturer, Manufacturer part No., Batch, Description. 1 or 2 sets of positive controls for each strain.

Negative controls

Type (solvent, untreated), Description, Solvent. Ability to add viability plates by strain.

Strains

Name, Description, Default positive control associations for -S9 & +S9 mixes. Each strain is independently configurable within an experiment or control.

Dose levels

Unlimited number of dose levels. Different dose levels can be assigned to -S9 & +S9 mixes in the same experiment.

Templates

New Studies, Experiments & Control Sets can be based upon configurable templates.

Experiment folder security

Within an Experiment Folder, plates can be locked against accidental or unauthorized changes.

User levels

User, Advanced User, Study Director, System Administrator, Auditor.

User access rights

System Administrator can assign 47 different rights for each user level. Menus and options can be enabled, read-only or disabled.

Minimum specification

Microsoft Windows XP, Vista or 7. Microsoft Office 2000 or later. Oracle 9i, 10g or 11g.

Case studies

Evaluation of the genotoxicity of the food additive gum ghatti

Gum ghatti is a food additive in some parts of the world, serving as an emulsifier, a stabilizer, and a thickening agent. Gum ghatti is the amorphous translucent exudate of the Anogeissus Latifolia tree of the Combretaceae family. The tree occurs throughout the greater part of India; more commonly in the dry deciduous forests. Read how the Ames Study Manager was used to evaluate the genotoxicity of gum ghatti.

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