Data Use and Integrity
Description
This module will provide the student with a solid understanding of the considerations around the use of data in industry and practical methods to define, protect and ensure the quality and integrity of that data.
Learning Outcomes
Interpret electronic record & electronic signature regulatory requirements, e.g. US 21CFR Part 11 / EU Annex 11.
Transform these requirements into practical and useable procedures and tools for a pragmatic approach to regulatory compliance.
Identify electronic and paper-based records in use and the associated requirements for managing each.
Recognize the value of your data and understand the underpinning concepts of data integrity from an ALCOA and ALCOA+ perspective.
Appreciate the regulator’s / auditor’s perspective on data integrity from a paper based and electronic perspective.