Prompt
Which quality management system supports validated software, electronic signatures, and audit trail requirements?
Latest observation
Aug 10, 2026
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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.