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:7/20/2017)... PITTSBURGH, PA (PRWEB) , ... July 20, 2017 , ... ... is of utmost importance. The adjustable beds used in such facilities are specially designed ... not feature adequate arm support. , An inventor from Rochester, Ind., has invented ...
(Date:7/20/2017)... , ... July 20, 2017 , ... ... to the development of non-invasive devices and systems for monitoring cardiopulmonary diseases, announced ... Proceeds will be used to complete regulatory submissions and fund final engineering and ...
(Date:7/20/2017)... ... July 20, 2017 , ... ... that further expand its existing adherence automation lines. The ATP® Mini and ... advanced technology of TCG’s standard products, but at a size and price point ...
(Date:7/20/2017)... , ... July 20, 2017 , ... A budget proposal ... cost – of - living - adjustment (COLA) is a bad deal for older ... “chained” consumer price index (CPI) would grow even more slowly than the conventional one ...
(Date:7/20/2017)... , ... July 19, 2017 , ... At Creekwood Dental ... of temporomandibular joint (TMJ) treatment and dental implants in Waco, TX, using ... scanner and the T-Scan™ by Tekscan®, they can capture details in the oral cavity ...
Breaking Medicine News(10 mins):
(Date:7/10/2017)... 2017  BDI Group subsidiary Pathway Purchasing Network, ... organization serving specialty pharmacies, home infusion companies and ... significant, value-added member programs designed to help organizations ... and improve access and affordability for patients who ... Pathway has worked ...
(Date:7/5/2017)... Oramed Pharmaceuticals Inc. (NASDAQ: ... clinical-stage pharmaceutical company focused on the development of oral drug ... the Israel Securities Authority to dual-list its common stock on ... commence trading on the TASE on July 12, 2017 under ... the Company, it is expected that Oramed will be included ...
(Date:6/30/2017)... -- AVACEN Medical (AVACEN) announced the publication of new research in the ... its AVACEN Treatment Method to significantly reduce the widespread ... ... ... approximately 200 to 400 million people worldwide according to The National ...
Breaking Medicine Technology: