Category: CSV/CSA

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Software Fundamentals – Writing Test Scripts to Support CSA

Presented by: Vignesh Srinivas, Service Delivery Manager, Zifo RnD Solutions •    Learn different types of testing – Exploratory, unscripted, and scripted testing•    Understand the difference between Robust test script, Bounded test script (scripted testing) and Unscripted test script (unscripted testing)•    Understand Risk Priority Value and how it is used to determine the […]

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(Panel) CSA – The Foundation for Digital Transformation

Presented by: David DeLuca, Director, Engineering & Validation, Compliance GroupFrancisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDABill Lee, Director of Information Services, DAP Health In an era where digital transformation is pivotal, the Compliance Group (CG) is proud to host a panel discussion uniting industry experts with a shared vision to “make quality […]

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Computer Software Assurance (CSA) Implementation with Focus on Industry Case Study

Presented by: Linda Lagrou, Senior Manager IT Quality, Abbott LaboratoriesGaurav Walia, Senior Global Director and Sr. Associate Partner, PQE Group •    Demonstration of CSA practical execution•    Real world highlights of CSA implementation case study•    Use of critical thinking with the implementation•    Use of automation tools with the CSA Approach•    Overarching […]

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CSV – Effective System Level Risk Assessment

Presented By: Rohit Tyagi, President, SAGAX Team Key Highlights: Regulatory Compliance: How implementing robust CSV processes is essential for pharmaceutical companies to ensure product quality and patient safety, while remaining compliant with regulations. Risk Identification: Learn how to properly assess risk in using a computerized system focusing on patient safety. Data Integrity Assurance: Identifying potential […]

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