Auditing of Computer System Validation to Ensure Data Integrity

FDA inspectors and corporate auditors must be able to recognize the critical aspects of computerized systems and the documentation needed to demonstrate that they are validated. This course provides an approach to inspecting/auditing these systems and covers the detailed review of systems that automate part of the production process or part of a quality system. Topics in this course include: 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. Prerequisites for this course include Introduction to Data Integrity and either the Computerized Systems Inspections in the Medical Device Industry or the QSIT 5 — The Production and Process Controls Subsystem course.

Recognize the requirements for data integrity, validation activities, and documentation. Recognize an approach to inspecting computerized systems when a detailed review of those systems is needed.