Information Technology
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Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements
Description: 21 CFR Part 11 provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to... -
Project Management for Computer Systems Validation
Description: Project Management is defined as the planning and organization of an organization’s resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that...