Navigation Links
Axela introduces software to support 21 CFR Part 11 Compliance for Regulated Environments
Date:5/7/2009

TORONTO, May 7 /PRNewswire/ - 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.


'/>"/>
SOURCE Axela Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Senate Introduces Legislation to Increase Access to Physical Therapist Services
2. Howard Leight Introduces QuietDose(TM): In-Ear Dosimetry Measures Noise Exposure in Real-Time to Help Prevent Workplace Hearing Loss
3. Video: Jewelry Television(R) Introduces DermaGem(TM)
4. SignatureForum Introduces NewImageSpecialists.com
5. Microsoft Introduces Groundbreaking Technology for Life Sciences
6. Verathon(R) Introduces BladderScan(R) BVM 9500 Bladder Volume Instrument To Help Urologists Diagnose Bladder Dysfunction
7. Working Towards Counting Malaria Out Through Scale-Up of PermaNet(R) Bed Nets, Vestergaard Frandsen Produces 175 Millionth Net; Introduces New Net To Combat Insecticide Resistance
8. AdEx Media Introduces RezActiv(TM)
9. Chill Cooling Towels Introduces Instant Relief for Hot Flashes and Night Sweats
10. PercSys Introduces Accordion CoAx(TM) Stone Control Device for Facilitating Percutaneous Kidney Stone Treatments
11. Lumenis Introduces the HoLEP Simulator and the PolyScope Disposable Ureteroscope at American Urology Association 2009 Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs ... College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. ... treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, ... and his M.D from the David Geffen School of Medicine at UCLA. He trained ... Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where ...
(Date:6/25/2016)... ... 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland ... iHire in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness ... & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... June 23, 2016  In a startling report released today, ... residents by lacking a comprehensive, proven plan to eliminate prescription opioid ... ranking of how states are tackling the worst drug crisis in ... states – Kentucky , New Mexico ... . Of the 28 failing states, three – ...
(Date:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... their offering. The current ... environment for MedImmune to enter. The US ageing population creates ... drive considerable growth for effective anti-influenza medications. The introduction of ... but development is still in its infancy. ...
Breaking Medicine Technology: