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ROI CalculatorFDA 21 CFR Part 11 is the section of the US Code of Federal Regulations that sets the rules for using electronic records and electronic signatures in FDA-regulated industries so they are trustworthy, reliable, and legally equivalent to paper records and handwritten signatures. It applies when electronic systems create, modify, maintain, archive, retrieve, transmit, or submit records under FDA requirements.
Key requirements:
• System validation to show systems work as intended.
• Secure, unique user identification and access controls.
• Audit trails that record who did what and when.
• Electronic signatures that link to records with name, date/time, and intent.
Why it matters: helps ensure data integrity and regulatory acceptance of digital records.
