FDA Part 11 Compliance and Medical Device Data Integrity Training
FDA Part 11 compliance involves so much more than e-signing documents and storing them securely. In this class, we will guide you through all facets of compliance with FDA 21 CFR Part 11 requirements governing electronic signatures and records. You’ll see excerpts referencing data integrity from several real FDA warning letters, and review six common misconceptions that companies have about Part 11 compliance. At the conclusion of this class you will understand why FDA places so much emphasis on computer system controls, how Part 11 ensures data integrity, the “predicate rules” related to electronic records, and your overall Part 11 obligations.