Electronic Signature vs Digital Signature (Part 11 Made Simple)
Introduction
Teams often confuse electronic signatures (e‑sign) with digital signatures. In Part 11 contexts, you need to prove identity, intent, and linkage to the record. Cryptography can help—but it’s not always mandatory. Here’s the clear view.
E‑sign in regulated environments
An e‑sign is data in electronic form that a person adopts as their signature. In Part 11‑aligned systems, that means: unique credentials, controlled access, time‑stamps, and the meaning of the signature (reviewed, approved, authored).
Digital signature (cryptographic)
A mathematical technique (public/private key) used to verify authenticity and integrity of a file. Great for externally shared PDFs or where tamper‑evidence must be portable.
When to use which
- E‑sign: Internal records—document approvals, CAPA closure, training acknowledgments.
- Digital signatures: External documents (certificates, PDFs) that need cryptographic validation beyond the system boundary.
What regulators expect
- Unique user IDs and RBAC
- Clear linkage: signature bound to the record (not separable)
- Time‑stamped trail entries
- Identity verification (e.g., password at signing, MFA per policy)
Common mistakes
- Scanned wet signatures treated as e‑sign without controls
- Shared accounts for approvals
How an eQMS helps
- Built‑in e‑sign prompts for meaning at sign time
- Signature stored with the record and in the trail
- AI Assist: drafts approval comments from long notes for reviewers to fine‑tune
FAQ
Do we need MFA for every e‑sign? Follow your risk policy; many require re‑authentication at sign.
Are digital signatures required? Not universally. Use them where they add value (e.g., external PDFs).
Conclusion
Use e‑sign inside your quality system; add digital signatures where portability and cryptographic proof are needed. Both can coexist cleanly.
