INTRODUCTION
21 CFR Part 11 is an FDA guidance that sets out how organizations operating in the United States can use electronic records and digital signatures in their quality management systems to replace paper- based documents and ‘wet signatures’.
Any organization that uses quality management and needs to conform to FDA regulations, such as pharmaceutical and life sciences organizations, needs to be aware of 21 CFR Part 11, and be compliant.
This document takes you through 4 stages of compliance – with individual checklists for each.
- Part 1. Validation
- Part 2. An Audit Trail for Every Document
- Part 3. Copies of Records
- Part 4. Record Retention