The endorsed Micro Focus independent software user group, Vivit Worldwide, is here for you through Advocacy, Community, and Education. We want to help our members, both Customers and Partners, obtain the maximum benefits from their investments in Micro Focus. Whether you are a current member of Vivit or looking to become a member, our membership is free and our local user group events are open for ALL to attend.
- 5 - 5:15 – Introduction from VIVIT's Local User Group
- 5:15 - 5:30 – Introduction from Sponsors (Checkpoint Technologies)
- 6:00 - 6:30 – Session 1 (Harvard Pilgrim Health -- Automation Transformation Journey)
- 6:30 - 7:00 – Session 2 (Tx3 Services -- Computer System Validation)
- 7:00 – 7:15 – Q&A , raffle and closing comments
- 7:15 – 8:00 – Dinner
Session 1 by Vijaya Bhaskara Reddy Ankireddypalli, Harvard Pilgrim Health
Automation Transformation Journey: Evaluation in software development methodologies has not only impacted the manner in which software products are developed but have also turned software testing and QA on its head. Now testing is not a solitary function anymore. IT organizations are realizing the role of Automation Transformation is more important in the development of robust, high quality, and error-free software.
Session 2 by Eric Toburen, Managing Partner and co-founder of Tx3 Services
Computer System Validation (CSV) is a critical requirement for any life sciences company. CSV verifies that computer systems and their associated applications operate in a consistent fashion and yield reproducible results based on their intended use. Such validation is aimed at ensuring patient safety, product quality, and data integrity when manufacturing regulated products. CSV is a stringent requirement of the US Food and Drug Administration (FDA). While documents and documentation have been the mainstay of compliance in the pharmaceutical industry for years, the advent of new digital technologies is opening up vistas to a better approach to validation...one that does not rely on documents (paper or electronic), but instead focuses on the data, providing a more comprehensive, integrated, and collaborative effort.
Recent statements by the FDA tout a renewed focus on “making risk-based regulatory decisions more modern, more scientifically rigorous, and more efficient.” This presentation will focus on how a data-driven approach extends this focus to Computer System Validation.
#Vivit, #CSV, #AutomationTransformation, @Checkpointech, @Tx3Services, @MicroFocus
Parking in the Visitor Lot or in the Garage will be free in the evening. Enter in the back or front entrance.