Software and documentation to provide a valuable resource for the implementation of chromatography data system in regulated environments
Thermo LabSystems announces the release of the Validation Toolkit for version 2002 of its Atlas CDS (chromatography data system). The toolkit comprises software and documentation to provide a valuable resource for the implementation of Atlas in regulated environments.
The new toolkit offers a number of major advances over previous versions, including a redesigned automated test driver, which has proven successful as the standard driver across all Thermo LabSystems's software product validation kits. The automated test driver allows users improved control over which tests to run as part of their own validation and provide single mouse-click access to results for review; all within a modern user-friendly interface.
In addition to the automated test driver, the Atlas 2002 Validation Toolkit includes: compiled automated test scripts; manual test scripts for every automated test in Microsoft Word format - to allow customers the option to run tests manually; visual test source code - to allow customers to verify the levels of testing complies with their own validation plan; functional specifications - to allow customers to tailor testing to incorporate their own workflows and standard operating procedures; test approach/functional specification matrix.
The latest version of the Validation Toolkit also contains a comprehensive set of tests to support customers in the validation of Thermo's DataServer and A2D instrument data acquisition and control devices, which are supplied to customers with Atlas CDS.
Malcolm Fowler, head of the software testing team at Thermo LabSystems, commented: "The inclusion of the acquisition device tests in the kits particularly will improve the efficiency of customers performing validation on their Atlas systems and reduce the time required to design their own test cases.
These tests are used as part of Thermo's own testing and, as such, have been designed using the same processes used in Atlas's development, which either meet or exceed the requirements of ISO 9001.
We have also released a manual version of the Installation Qualification (IQ) kit with Atlas 2002, which helps users make more informed decisions on whether any failures detected in the automated tests are significant to the product".
Fowler adds: "As to the future, we are always looking for ways to improve the toolkits to reflect new requirements and meets the needs of Atlas customers around the world.
For Atlas 2002 Release 2 later this year for example, we plan to provide an 'internationalized' IQ kit that will run using Italian, German, French and Spanish versions of Microsoft Windows NT." Atlas is a modern chromatography data system focused on delivering laboratory productivity by adapting to laboratory workflow and offering improved ease of use.
Its design means it is highly scaleable and as applicable for single workstations as it is for networked laboratories with multiple users and channels.
Atlas facilitates full compliance with the FDA's 21 CFR Part 11 Ruling on electronic signatures and records.
Customers can order copies of the latest Atlas Validation Toolkits through their local office or by visiting Thermo LabSystems's online store (link above).
