This course presents the regulatory requirements and best practices for medical device documents, documentation, and record keeping. It covers the differences between documents and records, the ISO 9001 document hierarchy and appropriate content for each document level, record-keeping requirements (including for 21 CFR Part 11), and the appropriateness of Excel spreadsheets for record keeping. The course also reviews general good documentation practices, incorporating the requirements of the FDA's Guide to Industry Data Integrity and Compliance with CGMP.
