Compliance
Two-person e-signature
four eyes · dual signature · independent review
Preparer + independent reviewer — required for MMRs and many GMP approvals.
21 CFR 211.186 (pharma MMR), 211.188 (BMR review), 111.205 / 111.260 (dietary supplements MMR / BPR), and 820.40 (device document approval) all require the approval to be performed by someone other than the preparer. V5 blocks the second signature if the second user is the same person as the preparer, and records both identities on the artefact.
Regulatory anchors
- 21 CFR 211.186
- 21 CFR 111.205
Related terms
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