When regulators knock, when auditors arrive, when your board asks for proof — Quays Enterprise delivers the controls, evidence, and uptime your organization demands.
Trusted by regulated enterprises worldwide
Pre-configured frameworks, terminology, and validation packages for the verticals where compliance is non-negotiable.
GxP-validated environments, 21 CFR Part 11 e-signatures, EMA Annex 11, and full GAMP 5 documentation packages out of the box.
IATF 16949 for automotive, AS9100 for aerospace, and ISO 9001 templates with NCR/CAPA workflows tuned for shop-floor velocity.
SOX-ready audit trails, segregation of duties controls, and policy attestations integrated with your IGA and ITSM stack.
HIPAA BAA, HITRUST-aligned controls, joint commission readiness, and credentialing workflows for clinical operations.
NERC CIP evidence collection, ISO 14001 environmental compliance, and ISO 45001 safety incident management at scale.
FedRAMP Moderate roadmap, FISMA-aligned controls, CMMC Level 2 templates, and US-only data residency with cleared support.
SOC 2 Type II, ISO 27001, GDPR, HIPAA. Pre-built control frameworks for FDA 21 CFR Part 11, ISO 9001/13485/27001, GxP, and more.
Zero-trust architecture, per-tenant encryption keys, IP allow-listing, SAML SSO with SCIM provisioning, and granular RBAC down to the field level.
99.99% uptime SLA backed by financial credits. Multi-region active-active deployment. RTO < 1h, RPO < 5min for critical services.
Named CSM and solution architect. White-glove onboarding in 4 weeks. Quarterly business reviews. Direct line to engineering for critical issues.
| Tier | Response time | Resolution target | Channels |
|---|---|---|---|
| P1 — Service down | < 1 hour | < 4 hours | 24/7 phone, Slack, email |
| P2 — Major degradation | < 2 hours | < 8 hours | 24/7 Slack, email |
| P3 — Minor issue | < 4 hours business | < 2 business days | Email, portal |
| P4 — Question | < 1 business day | Best effort | Portal |
Quays is the flagship product of Empbi — a 20-year quality and compliance consultancy serving Fortune 500 manufacturers, life sciences companies, and global regulators across the Americas. You’re not just buying software. You’re partnering with a team that has walked thousands of audits.
Real outcomes from teams who replaced spreadsheets, SharePoint, and legacy QMS suites with Quays.
"We consolidated four legacy tools into Quays and cut our internal audit prep from six weeks to four days. The auditors literally said it was the cleanest evidence package they had ever seen."
"The SAML SSO + SCIM rollout took an afternoon. Field-level RBAC let us give external auditors view-only scoped access without spinning up a separate environment. That alone saved us a quarter of legal review."
"We went live across 14 sites in 5 weeks. The dedicated solution architect rebuilt our entire CAPA taxonomy on a shared Miro and shipped the workflows the next sprint. Nothing else on the market is that responsive."
Most enterprise customers go live in 4 weeks. Here is exactly what those weeks look like.
Choose the residency, isolation, and key-management model your security and legal teams require.
Shared infrastructure with logical isolation, AES-256 at rest, TLS 1.3 in transit, and platform-managed keys. Fastest path to value.
Single-tenant infrastructure in your chosen region with customer-managed encryption keys via AWS KMS or Azure Key Vault.
GovCloud, EU-only, or in-country data residency for FedRAMP, BaFin, and equivalent sovereign requirements.
Independent attestations and pre-mapped control frameworks. Request the latest reports under NDA from your CSM.
Tell us about your environment. A solutions architect will reach out within one business day.