The Ames Archive ManagerTM is the latest addition to our suite of
software for regulatory Ames testing. The program has been
developed in accordance with the OECD series on principles of GLP
and compliance monitoring number 15: Establishment and Control of
Archives that Operate in Compliance with the Principles of GLP.
The program offers extensive searching and filtering capabilities,
helping you find specific studies for archiving quickly and easily. Once
archived, a study cannot be modified in any way, yet retains
accessibility for report reconstruction, auditing and verification.
Features
- Reconstruct archived studies for reporting, auditing and verification
- Lock down study data whilst retaining flexibility to view or report on original data
- Developed with reference to OECD guideline principles of GLP and compliance monitoring number 15
- Easy browsing, sorting and filtering of all your Ames studies, past and present
- GLP and FDA 21 CFR Part 11 compliance with audit trails, user permissions and database security
- Comprehensively tested and validated in accordance with our Quality Management System which is approved to ISO 9001:2008 incorporating ISO 90003
A safe and secure archiving utility for those seeking GLP compliance
The Ames Archive Manager is aimed at those wishing to archive their assay data in line with the
OECD guideline on the ‘Establishment and Control of Archives that Operate in Compliance with the
Principles of GLP’. The program works in conjunction with the Ames Study Manager and its associated
modules to provide the complete solution for regulatory Ames testing.
A safe and secure archiving utility for those seeking GLP compliance
The Ames Archive Manager allows users to select individual studies or a range of studies to be
archived in just one simple action. In order to maintain the integrity and accessibility of your
data, the Ames Archive Manager works by simply marking selected studies as archived, and so does
not remove any data from your original Ames database. This not only helps ensure the integrity
of your data by avoiding any potentially dangerous export and purge operations, but also means
you can still view the study and reconstruct reports for auditing and verification.
Auditing and user administration helping you meet regulatory requirements
The Ames Archive Manager has been designed and developed with reference to a wide range
of regulatory guidelines and when used in conjunction with the System Access Manager is fully
compliant with Good Laboratory Practice and the FDA 21 CFR Part 11 final rule on electronic
records and electronic signature. The program has been tested and validated in accordance with
our Quality Management System which is approved to ISO 9001:2008 incorporating ISO 90003.
Comprehensive audit trails record every action taken within the program, including both the
archiving and unarchiving (where allowed) of study data. These audit events can be viewed not
only from within the Ames Archive Manager itself, but also from the main Ames Study
Manager main event log.
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