Module25 April 20264 min read
Module spotlight: Electronic Signatures
An approval is only meaningful if you can prove who gave it. Electronic signatures make every sign-off a deliberate, attributed, 21 CFR Part 11 compliant act.
By MoniDoseQMS Team
In a regulated quality system, a signature is not a formality — it is a legal commitment that a specific person reviewed or approved a specific record. Electronic signatures in MoniDoseQMS make that commitment deliberate, attributed, and tamper-evident, without the friction of paper.
What you can do
- Draw your signature once and reuse it across the platform
- Sign any record with your role and password re-authentication
- Capture the meaning of each signature — authored, reviewed, approved
- Configure 1-, 2-, or 3-step author / reviewer / approver workflows
Why it matters
FDA 21 CFR Part 11 sets the bar for trusted electronic signatures: identity, intent, and meaning, all recorded. Password re-authentication and a locked audit trail make each signature as defensible as a wet-ink one — and far faster to apply.