Simpleafied VeritasInfrastructure
SYSTEM ACTIVE • 21 CFR PART 11 / EU ANNEX 11 VERIFIED

Compliance intelligence for life sciences.

Veritas operates as the underlying compliance infrastructure layer for emerging biotechnology and pharmaceutical enterprise.

01 / COMPLIANCE GRAPH ARCHITECTURE

Every regulation maps directly to operational evidence.

Regulations → Processes → Documents → People → Evidence operate in autonomous real-time alignment.

LIVE TOPOLOGY SYNC
SYSTEM: VERITAS GxP GRAPH v2.4
LATENCY: 0.2ms
21 CFR PART 11 / EU ANNEX 11 VERIFIED
REGULATIONSEU ANNEX 11 / PART 11STATUTORY RULEPROCESSESCAPA & WORKFLOWSENFORCEDDOCUMENTSCONTROLLED SOPsSHA-256 VERIFIEDPEOPLEQUALIFICATIONS100% READYEVIDENCEAUDIT LEDGERIMMUTABLE LOG
REGULATORY SCOPEEU Annex 11 • FDA 21 CFR Part 11
PROPAGATION SPEEDReal-time (< 50ms latency)
AUDIT VERIFICATIONSHA-256 Cryptographic Ledger
02 / PRECISION WORKFLOW

Digital signatures with SHA-256 integrity verification.

CONTROLLED RECORD ACTIVE
CLASSIFICATION: GxP RESTRICTED
STATUS: APPROVED / EFFECTIVE
SOP IDENTIFIER: SOP-QA-042

Cell Therapy Batch Release Protocol v3.0

Effective Date: 2026-07-26 • Review Cycle: Annual • Owner: QA Department
SHA-256: e8f9a2b4...9d12
"This procedure defines statutory release criteria for biological products compliant with EU Annex 16 and FDA 21 CFR Part 211."
ER
Dr. Eleanor Vance
Head of Quality Assurance • Timestamp: 2026-07-25 14:32:08 UTC
✓ 21 CFR PART 11 VERIFIED
03 / PERSONNEL QUALIFICATION

Automated qualification tracking.

ROLE-BASED PERSONNEL MATRIX
READINESS: 100% AUDIT READY
PERSONNEL & ROLE
QUALIFICATION SOP
COMPLETION DATE
STATUS
Dr. Marcus Vance
Analytical Lead
SOP-QA-042 (v3.0)
2026-07-25
QUALIFIED
Sarah Jenkins
QC Specialist
SOP-LAB-012 (v2.1)
2026-07-24
QUALIFIED
David Chen
Process Engineer
SOP-ENG-088 (v1.0)
2026-07-22
QUALIFIED
04 / IMMUTABLE AUDIT LEDGER

Immutable audit logs recorded in real-time.

Every signature, approval, revision, and permission change is cryptographically hashed and instantly exportable for regulatory inspections.

VERITAS IMMUTABLE AUDIT LEDGER
FILTER: ALL EVENTS
[EXPORT INSPECTION PACKAGE ZIP]
[AUDIT-RECORD-2026-07-26T06:45:12.082Z] EVENT: ELECTRONIC_SIGNATURE_EXECUTED
AUTHENTICATED_USER: usr_9942a188 (Dr. Eleanor Vance — Head of QA)
RESOURCE_IDENTIFIER: doc_sop_qa_042_v3 (Batch Release Protocol v3.0)
SIGNATURE_AUTHORITY: APPROVAL_AUTHORITY_FINAL
STATUTORY_COMPLIANCE: 21 CFR Part 11 / EU Annex 11 Verified
CRYPTOGRAPHIC_CHECKSUM: 3f8a91c2b5d4e6f7a8b9c0d1e2f3a4b5c6d7e8f9a0b1c2d3e4f5a6b7c8d9e0f1
05 / ARCHITECTURE FOR GROWTH

Designed for biotechnology enterprise.

01 / DEPLOYMENT SPEED

Inspection-Ready in 48 Hours

Bypass 6-month legacy vendor onboarding. Pre-validated GxP templates allow emerging life science teams to achieve complete regulatory readiness in days.

02 / ZERO AUDIT ANXIETY

Audit-Ready Guarantee

Automatic compliance evidence generation for EU Annex 11 and FDA 21 CFR Part 11 inspections, satisfying auditors, regulators, and Series A/B investors.

03 / CONNECTED INTELLIGENCE

Relational GxP Topology

Updating one SOP automatically recalculates role qualifications, flags required retraining, and logs immutable audit evidence with zero orphan records.

RESERVED WALKTHROUGH

Establish your quality foundation.

Schedule a 15-minute 1-on-1 walkthrough with a European GxP Quality Architect. See how Veritas prepares your biotech enterprise for regulatory inspection.