Document workspace · Cloud

Every submission.
Every revision.
One secure home.

Complizen Cloud is where your regulatory work lives — versioned, audited, role-gated, and fully traceable. SOC 2 Type II. HIPAA-aware. 21 CFR Part 11-compatible.

Projects / CardioFlex 510(k)
v12 · saved 2m ago
Submission Package14 filesIn review
510k_Cover_Letter_v3.docx2d ago · J. OkaforFinal
SE_Narrative_v7.docx6h ago · M. ChenIn review
Perf_Testing_v2.docxNow · YouDraft
Risk Management File8 filesFinal
ISO_14971_Hazard_Table.xlsx3d ago · R. ParkFinal
Version history · 47 revisionsView all →
What’s included

Everything a regulated document workspace needs.

Secure storage

AES-256 encryption at rest and in transit. Regional residency options for US and EU customers.

Version control

Every save is a version. Compare, restore, or branch any document. Full history for every revision by every user.

Bulk analysis

Upload an entire submission folder. Complizen analyzes all documents, maps relationships, flags duplicates and broken citations.

Role-based access

RA lead, engineer, QA reviewer, external consultant — each role gets appropriate access. Sections can be locked for final review.

Audit trail

Every action logged with timestamp, user, and change detail. Exportable as a 21 CFR Part 11-style log for your quality system.

Retention policies

Set document lifecycle rules per project or folder. Automated retention, deletion schedules, and hold policies for regulated data.

Enterprise-grade security

Built for the firms FDA already trusts.

SAML SSO, audit logs, IP allow-listing, data lifecycle controls, regional residency — all included by default, not add-ons.

See our trust page →
SOC 2 II
Type II audited
HIPAA
BAA available
GDPR
EU residency
21 CFR 11
e-records ready
Start storing securely

One workspace for your entire submission history.

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