Document management,
from draft to audit.
Most regulatory documents live in Word files, email threads, and scattered drives — until FDA asks for the signed version and your team scrambles. Complizen runs the full document lifecycle in one workspace: AI drafts the doc, your team reviews and signs off, every version is tracked, and everything stays in Complizen Cloud, audit-ready.
Word files. Email threads. Scattered drives. Lost sign-offs.
Sound familiar? Five years later, the auditor wants the signed version — and your team spends days digging through folders trying to figure out which one was actually approved.
One workspace for the full document lifecycle.
Start writing
- Pick a template or start blank
- AI fills gaps from device profile
- Citations auto-linked as you type
- Inline AI for rewrites & expansion
Invite reviewers
- Assign sections by role
- Threaded comments per paragraph
- Suggested edits with accept/reject
- External consultant access scoped
Lock and sign off
- Section-level approval workflow
- Version freeze at review milestones
- Electronic sign-off with audit trail
- 21 CFR Part 11-compatible log
Archive & track
- AES-256 encrypted storage
- Full version history forever
- Retention policies per document type
- Linked to submission & risk file
Ask Complizen to write any document you need.
Complizen writes regulatory documents from your device profile, your templates, or a simple prompt. You and your team edit, collaborate, and share — with full version history tracked in Complizen Cloud.
Every common regulatory doc, ready to use.
Pre-built templates for IFUs, V&V protocols, SOPs, CERs, risk plans, and more — refreshed as standards and FDA guidance update.
Bring your company's templates.
Upload them once. Reuse across submissions, devices, and teams — Complizen learns your formatting and language.
Just describe what you need.
Superagent searches eCFR, FDA guidance, recognized standards, and your device profile — and drafts the document from zero.