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Document Lifecycle & eSignatures

Every document.
Every revision state.
Fully controlled.

Confideck manages the complete document lifecycle — from authoring through review, approval, and release — with legally binding eSignatures compliant with FDA 21 CFR Part 11.

Regulatory Affairs Quality Management FDA 21 CFR Part 11 MDR / IVDR
5min

Average time to approve and release a document

How it works

One system for authoring,
review, approval, and release.

01
Authoring in context
Documents are authored directly in Confideck's proprietary editor — fully compatible with Microsoft Word, with regulatory structure enforced from the start.
Word compatible
02
Structured review workflow
Review steps are enforced in sequence. Reviewers are assigned, notified, and tracked — no email chains, no missed sign-offs, no version confusion.
Enforced sequence
03
Legally binding eSignature
Approvers sign electronically in compliance with FDA 21 CFR Part 11. Full identity verification, timestamp, and audit record captured automatically.
21 CFR Part 11
04
Version released & archived
Every approved version is locked, versioned, and retrievable at any point. Snapshot collections preserve the exact document state for audits and submissions.
Full audit trail

The outcome

What controlled document management
looks like in practice.

5min
Average approval and release time
vs. days of email chains, PDF routing, and manual version tracking across systems.
0
Unsigned or untraceable approvals
Every approval is captured with identity, timestamp, and statement — legally binding under FDA 21 CFR Part 11.
100%
Audit-ready version history at any point
Every revision state is preserved. Snapshot collections make it trivial to demonstrate the exact document state used for any submission or audit.