This course presents the regulatory requirements and best practices for pharmaceutical documents, documentation, and record-keeping. It includes a review of the differences between documents and records; the typical ISO 9001 document hierarchy, as well as an explanation and appropriate content of each document level; record-keeping requirements, including the electronic signature and the requirements of 21 CFR Part 11; and the appropriateness and qualification of Excel spreadsheets for record keeping. General good documentation practices, incorporating the requirements in FDA's Guidance to Industry, “Data Integrity and Compliance With cGMP,” are also reviewed.
