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Ironclad Compliance Architecture

QMSdesk Trust Center & Security Controls

Engineered from the database layer up as a 100% cloud-native SaaS platform to withstand FDA, EMA, and ISO regulatory inspections.

Cloud-Native GxP SaaS

Fully managed cloud platform with 99.9% uptime SLA. Dedicated Sandbox and Production environments with zero on-premise IT maintenance overhead.

Multi-Tenant Edge Isolation

Strict database schema segregation and edge-level middleware (`proxy.ts`) ensure zero cross-tenant contamination. Multi-region data residency available for US, EU, and APAC.

GENESIS Cryptographic Audit Trail

Every audit log row links to the previous row's SHA-256 checksum. PostgreSQL insert-only triggers (`reject_auditlog_mutation()`) mathematically block database alteration.

Enterprise SAML 2.0 & Bcrypt 12

Enterprise Single Sign-On (SSO) with Okta, Azure AD, and Ping. Bcrypt salt rounds standardized to 12 rounds with full dual-factor signature forensics.

Continuous Audit Verification

Automated daily verification jobs (`AUDIT_CHAIN_VERIFY`) scan the audit hash chain to guarantee 100% ALCOA+ data integrity before auditors arrive.

Automated Encrypted Backups

Automated continuous point-in-time backups encrypted at rest with AES-256 and in transit with TLS 1.3. Disaster recovery tested annually with sub-hour RTO/RPO.

Certified Regulatory Alignment

Cloud-Native GxP SaaSFDA 21 CFR Part 11EU GMP Annex 11ISO 13485:2016GAMP 5 Category 5SOC 2 Type II Certified Cloud InfrastructureHIPAA AlignedALCOA+ Data Integrity