An overview of Good Documentation Practices, including the differences between documents and records, the typical ISO 9001 document hierarchy, and each document level. Participants will become familiar with record-keeping requirements including the electronic signature and other regulations in 21 CFR Part 11. Additionally, the appropriateness and qualification of Excel spreadsheets for record-keeping will be reviewed along with how general good practices incorporate FDA compliance requirements outlined in the Guidance to Industry document Data Integrity and Compliance with CGMP.
