Unify instruments, ELNs/LIMS, and process data into an AI-ready backbone with audit trails, role-based access, and immutable provenance managed by tBrexa Bio’s life-sciences team.
Deploy fast, stay compliant, and unlock AI across R&D and manufacturing.
21 CFR Part 11, Annex 11, and ALCOA+ baked into identities, signatures, audit trails, time-sync, and immutable logs from day one.
Adapters for 200+ instruments and ELN/LIMS connectors (CSV, OPC-UA, HL7/FHIR, REST, MQTT). Keep workflows; gain a single source of truth.
Harmonized, versioned datasets with lineage for model training, predictive QC, and process optimization—without compromising compliance.
RBAC/ABAC, SSO/SAML/OIDC, encryption at rest & in transit, network isolation, key rotation, and least-privilege defaults for GxP environments.
Ops and quality dashboards for batch genealogy, deviations, CPP/CQA trends, and release readiness—all exportable to eQMS.
24/7 monitoring, validated change control, and white-glove onboarding by tBrexa’s data and regulatory team.
Supported Instruments
Uptime Guarantee
Time Savings on Data Tasks
Regulatory Compliant
Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available.
Immutable, time-synced events for create/update/delete, signatures, and data exports with reviewer notes.
21 CFR Part 11-compliant signatures with multi-factor identity binding and reason capture.
Risk-based validation templates (URS, FS, DS, IQ/OQ/PQ) and change-control playbooks.