Requirements of 21 CFR Part 11 :

1. System validation to ensure data security and integrity of record keeping
2. Audit trail to trace the development of a process
3. Restricted access for better security control
4. All system users must have essential training to perform everyday tasks
5. Record generation with search and indexing functionality for easy recovery
6. Quality procedures that instill operational control over people and process within the development cycle
7. Digital signature across the organization for a quick and easy approval process

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