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Glossary

Electronic Signature

Quality Management Glossary Term
Category
Training & Compliance
Industry
Manufacturing, Medical Device, Aerospace, Life Sciences
Required By
ISO 9001 · ISO 13485 · FDA 21 CFR Part 11
Related Terms
CAPA · Audit Management · Risk Assessment

An Electronic Signature is a legally binding digital method of signing records, approvals, and transactions within electronic systems. Electronic signatures help organizations improve efficiency while maintaining compliance with regulations such as FDA 21 CFR Part 11. 

What is Electronic Signature?

Electronic Signature is a key process or concept used within quality management systems to support compliance and operational excellence.

Why is Electronic Signature important?

Electronic Signature helps organizations improve traceability, maintain compliance, reduce risk, and support continuous improvement initiatives.

Frequently Asked Questions

What does Electronic Signature mean in quality management?

Electronic Signature refers to a quality management concept commonly used in regulated manufacturing industries.

How is Electronic Signature used?

Electronic Signature is typically used within a quality management system to improve process control and regulatory compliance.

Related quality management terms

Last reviewed: May 19, 2026