The 21 CFR Part 11 enabler for on-line TOC analysis. Electronic signatures, secure user management and a complete on-board validation suite for pharmaceutical water systems.
DataTOC delivers compliant, audit-ready total organic carbon analysis for pharmaceutical water systems — with electronic signatures, secure user management and a complete on-board validation suite.
Electronic signatures, role-based access control and a complete audit trail — built to satisfy 21 CFR Part 11 for electronic records and signatures.
Run calibration, verification, system suitability and linearity protocols from the 10.1″ touchscreen, backed by a full IQ / OQ / PQ support package.
Review and verify results with e-signatures, filter history by protocol and date, export certificates to USB and back up the database in seconds.
Every action on DataTOC is attributable, time-stamped and tamper-evident. From login to exported certificate, the analyzer enforces the controls your quality team expects — so audits become a formality, not a fire drill.
21 CFR Part 11 capabilitiesDataTOC adds 21 CFR Part 11 compliance to your TOC measurement — stainless-steel sample path, high-temperature and ozone compatibility included. Ask us whether it fits your current setup.
| Display | 10.1″ touchscreen |
|---|---|
| Outputs | Ethernet (Modbus TCP/IP), USB, two 4–20 mA, alarms |
| Sample temperature | 10 – 90 °C (50 – 194 °F) |
| Sample flow | 60 mL/min minimum at 15 – 100 psi (1.0 – 6.9 bar) |
| Power | 100 – 240 VAC ±10%, 60 W, 50/60 Hz |
| Dimensions (H × W × D) | 35 × 40 × 27 cm · 12 kg |
| Environment | Indoor use · ≤ 90% RH non-condensing · ≤ 3,000 m |
Continuous on-line measurement with selectable reporting intervals — see excursions as they happen.
Integrated sample pump for on-line, grab and low-pressure sampling points.
Data-Guard™ e-signatures, audit trail, role-based access and signed certificates — no external data system to buy or validate.
Calibration, verification, SST and linearity protocols, plus a complete IQ/OQ/PQ Validation Support Package in the box.
Wireless, Modbus TCP/IP, USB, dual 4–20 mA and alarms from a single enclosure.
Sample temperatures to 90 °C and ozone compatibility for hot WFI and sanitized loops.
Ask us for a demonstration or a quotation.
