HücreZinciri — Chain of Identity & Custody for Cell and Gene Therapies
Chain of Identity (COI) and Chain of Custody (COC) platform for CAR-T/ATMP therapies. Built for 21 CFR Part 11 compliance with a clinical-grade user experience; deployed as a dedicated instance and database per institution.
Wesentliche Merkmale
Chain of Identity (COI)
Unbroken patient-to-product identity with ISBT 128 Donation Identification Numbers (DIN) at every step.
Chain of Custody (COC)
Physical responsibility trail through custody handovers, shipment scans and sensor readings.
Immutable audit trail
Append-only tables with a SHA-256 hash chain and periodic Merkle checkpoints.
Bound e-signatures
Signatures bind to the hash of the signed record snapshot; administration requires two distinct verifiers.
9-state therapy order flow
Enrollment → collection → GMP → QC release → administration, with reconciliation: issued = used + spoiled + destroyed.
Field PWA
Offline-first PWA with an outbox queue; server-authoritative synchronization and conflict review.
Gemeinsam Ihre digitale Prüf-Infrastruktur aufbauen
Unser Team steht Ihnen gerne zur Verfügung, um zu erläutern, wie Omega CRO Ihre Anforderungen an klinische Prüfungen unterstützen kann.