In a regulated industry such as life sciences adapting latest digital trends is a huge challenge, I want to share some of the testing specific challenges, its solution and the best practices that eventually helped us adapt latest technologies with faster turnaround times. We are bound by FDA regulations and compliance requirements that prevent us from adopting new trends and technologies without going through due process. Such requirements pose a multitude of challenges within an application’s SDLC process, especially in the testing phase. Some of these challenges included inefficiencies in testing due to the use of multiple tools for end-to-end validation and complex approval workflows therein. We addressed these inefficiencies by the implementation of an integrated Application Lifecycle Management (ALM) toolset in combination with a flexible organizational QMS process. Another challenge we faced was when moving from waterfall to agile, we noticed a significant increase in testing effort and delays in projects. One of the steps to resolve this was by customizing our agile process and breaking the validation cycle into separate sprints within the release cycle. I will highlight some more challenges and how we resolved them with the help of technology and processes. In summary, a conference attendee will take away multiple best practices and solutions that can enable them to implement new trends and technologies with faster turnaround times in a regulated environment.
April 24 @ 10:50
10:50 — 11:30 (40′)