In this two-day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.

This presentation will provide auditors who are not knowledgeable about computer system validation with a basic understanding of the requirements and expectations for validation documentation. We will ...

Discuss the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational ...

Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but it also makes good business sense to ensure that computerized systems will perform consistently as expected.