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For many Life Science organizations, the risk of non-compliance has fostered a culture in which a blanket level of rigor is applied to all software testing. The result is costly and time-consuming delivery of software quality projects where the actual goal of quality testing and software is overshadowed by quantity of testing and documentation.
However, with the right tools, many organizations have been able to adopt a Risk-Based approach to their CSV programs, enabling the emphasis to be put back on quality and meeting business objectives.
Join Tx3’s Dori Gonzalez-Acevedo and Biogen’s Ajay Pandey as they discuss how to leverage Tx3 VERA and Micro Focus ALM to implement a Risk-Based approach to testing for a streamlined, mature CSV program. Some highlights include:
- Challenges of balancing Software Quality with Regulatory Compliance
- Leveraging tools to enable streamlined process
- Establishing risk profiles for more strategic and efficient software testing
- Demonstration of VERA and ALM for Risk-Based CSV Testing
Join us for this interactive session and get a chance to win a Livescribe Smart Pen!
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VP of Strategic Solutions
- 20 years in the pharmaceutical industry, specializing in regulatory compliance strategy and computer systems validation
- Started her pharmaceutical career developing FDA-approved manufacturing processes, then moved to operations quality groups
biotechnology firms where she established Risked-Based Quality Systems
- Focus has been on risk-based strategy and compliance since her start consulting at Genilogix, continuing through to her role as Director of Quality Systems for Healthcare and Life Sciences at Avnet
- Today as VP of Strategic Solutions at Tx3, Dori expands Tx3’s services with a focus on increasing current use of tools and advancing client understanding of compliance, automation, testing, and beyond
Senior Manager ALM Platform
- Senior IT professional with over 19 years of progressive experience in management and governance of Application Lifecycle Management/SDLC tool sets in large Medical Device and Bio-Pharmaceutical space
- Certified Project Management Professional (PMP).
*Ajay Pandey has agreed to participate in this presentation as an individual subject matter expert, and his views and thoughts discussed herein are not necessarily shared by his employer, Biogen, nor should any mention of Tx3 or Micro Focus products or services be interpreted as endorsements by Biogen.
#VivitLUGEvent, #ALM, #VERA, #Risk-Based, #CSVTesting, #SoftwareQuality, #RegulatoryCompliance, @Tx3Services, @MicroFocus
Join this meeting at : https://attendee.gotowebinar.com/register/8299833261883123212.