Assay System supports 21 CFR Part 11 compliance.May 22, 2009 -
Used for development of assays for monitoring protein production and biomarker quantitation, dotLabŪ System is available with software that provides technical controls to support 21 CFR Part 11 compliance. Features include secure database, audit trails, electronic signature controls, and user name/password controls. Software also aids implementation of controlled assays and provides users with flexible single platform for assay development, validation, and transfer between labs.
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Original Press release
Axela Inc.
480 University Avenue
Toronto, , M5G 1V2
Canada
Axela Introduces Software to Support 21 CFR Part 11 Compliance for Regulated Environments
TORONTO, May 7 -- Axela Inc., is pleased to announce the release of a software package for the dotLab(R) System that provides technical controls to support compliance with 21 CFR Part 11 regulations. This new package will be of particular interest to those working in pharmaceutical, biotech or other regulated environments. Features include a secure database, audit trails, electronic signature controls and user name/password controls.
"The dotLab System has proven its value in the rapid development of assays for monitoring protein production and biomarker quantitation. Axela is committed to further expanding the applications for our technology platform and increasing functionality" said Rocky Ganske, President and CEO, Axela Inc. "The new 21 CFR Part 11 Compliance Support Software simplifies implementation of controlled assays and provides dotLab System users with a flexible single platform for development, validation and transfer of assays between labs."
This new software is an integral component in Axela's suite of tools that significantly accelerate biomarker and assay development. Based on unique optics technology, the dotLab system allows reagent qualification, assay development and routine quantitative analysis to be combined into a single platform. panelPlus(TM) Sensors provide the industry's first real time, user configurable multiplex and have been designed to facilitate validation of both clinical utility and analytical performance. Panel constituents selected from a menu of established biomarkers can be freely combined with proprietary targets to allow direct comparison in a single sample. To further facilitate independent validation the same reagents are available in an orthogonal plate based EIA format. panelPlus Sensors are currently in use by Axela collaborators and will be commercially available this summer.
About Axela Inc.
Axela's products deliver rapid understanding of biological interactions, and use real time information to significantly improve the amount and quality of information derived from traditional immunoassay. This approach shortens time to result, greatly simplifies multiplexing and provides access to unique categories of markers that form a pipeline of future diagnostic offerings. Axela has operations in Toronto and California. Its major investor is VenGrowth Private Equity Partners Inc.
CONTACT: To order or for more information, please visit http://www.axela.com/ or contact: Mr. Paul Smith, VP Sales and Business Planning, Axela Inc., Phone: (416) 260-9050 x2291, E-mail: p.smith@axela.com
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