New: AI Compliance Intelligence — automate gap analysis across 30+ standards. Read the announcement
Security

Audit-ready document control

21 CFR Part 11 e-signatures, version control, immutable audit trails, and document workflows that keep regulators — and your auditors — happy.

Trusted by regulated teams

21 CFR Part 11
compliant e-signatures
ISO 9001/13485
pre-built frameworks
100%
audit trail coverage
0 findings
on document control across 50+ audits

Electronic signatures (21 CFR Part 11)

Legally binding e-signatures with reason for signing, dual-factor authentication, and tamper-evident audit trails for every document action.

Versioning & change control

Major/minor versioning with mandatory change requests, peer review, approval workflows, and automatic obsolescence of superseded revisions.

Document lifecycle workflows

Configurable draft → review → approval → release → periodic review cycles. Reminders, escalations, and read-and-understood acknowledgments built in.

Immutable audit trail

Every view, edit, signature, comment, and download is recorded with user, timestamp, IP, and reason. Export to your SIEM via webhook or syslog.

Controlled distribution

Watermarked PDFs, role-based access, expiring read links, print tracking, and acknowledgment requirements for new revisions.

Compliance vulnerability scanning

AI-powered analysis flags missing controls, outdated SOPs, untrained personnel, and overdue reviews — before your auditor finds them.

Unlock world-class
quality management

Join 2,000+ organizations that trust Quays to manage quality, compliance, and continuous improvement. See how it works for your team.