Screenshot of a blue and gray abstract background.

Medical Devices, Pharmaceuticals

Auditing of Computer System Validation to Ensure Data Integrity

About the Course

Auditing computer systems for compliance with FDA rules and international standards requires knowing what to look for in validation documentation. Ths course helps IT and Quality Systems professionals understand these issues: Data Integrity and Governance, Validation and the SDLC, Key Documentation Deliverables, Requirements, Design and Configuration, Implementation and Verification, and Maintenance. After completing this course, learners will be able to recognize validation activities and the maintenance of the validated state as it relates to data integrity. After completing this course, you will recognize the requirements for data integrity, validation activities, and documentation. You will also recognize an approach to inspecting computerized systems when a detailed review of those systems is needed.