This course presents the regulatory requirements and best practices for medical device documents, documentation, and record keeping.  Topics covered will include: a review of the differences between documents and records; the ISO 9001 document hierarchy as well as an explanation and appropriate content of each document level; record keeping requirements including the electronic signature and record keeping requirements of 21 CFR Part 11; and the appropriateness and qualification of Excel spreadsheets for record keeping.  General good documentation practices incorporating the requirements detailed in FDA's Guidance to Industry "Data Integrity and Compliance with CGMP" are also reviewed.