Prompt
Which quality management system supports validated software, electronic signatures, and audit trail requirements?
Latest observation
The standard most directly associated with validated software, electronic signatures, and audit trail requirements is 21 CFR Part 11 from the U.S. FDA.
If you mean a broader quality management system (QMS) rather than a regulation, then the relevant QMS framework is typically ISO 13485 for medical devices, often implemented alongside 21 CFR Part 11 to cover those electronic records/signature controls.
If you want, I can also explain the difference between ISO 13485, 21 CFR Part 11, and GxP compliance in one table.
Observation history
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