The market opportunities lie in providing comprehensive training for computer system validation aligning with FDA regulations, offering hands-on practice, agile and waterfall methodologies comparison, ...

FDA emphasizes data integrity in its inspections of computer systems within regulated industries, focusing on compliance and consumer safety. This press release covers best practices in system ...

Abstract: Autonomous Driving Systems (ADSs) are safety-critical systems, where even minor errors can lead to significant consequences. Therefore, thorough testing of ADSs is essential. Scenario-based ...

DUBLIN--(BUSINESS WIRE)--The "Digital Validation Demystified - GAMP® 5 2.0 and CSA Integration" training has been added to ResearchAndMarkets.com's offering. This course equips you with the tools, ...

DUBLIN--(BUSINESS WIRE)--The "A Risk Based Approach to IT Infrastructure Qualification, Compliance & Control" has been added to ResearchAndMarkets.com's offering. The FDA has intensified its focus on ...

Abstract: The report, Curriculum Guidelines for Undergraduate Degree Programs in Computer Engineering (CE2016), developed by the Association for Computing Machinery and the IEEE Computer Society, was ...

A complete, audit-ready Computer System Validation (CSV) portfolio project. Demonstrates the full validation lifecycle per FDA 21 CFR Part 11 and GAMP 5 for a mock clinical trial system, including URS ...

SIOUX FALLS, S.D. (KELO) — Power has been restored after the State of South Dakota faced widespread computer issues. According to a press release from the state’s Bureau of Information Technology (BIT ...