The first passive, out-of-band cryptographic interceptor that guarantees FDA 21 CFR Part 11 compliance—without touching your validated operating system.
Apply for Enterprise PilotModern biopharma labs spend millions on ISPE GAMP 5 Category 4 software validations. Every OS update, patch, and network change requires a crippling re-validation cycle. Furthermore, software alone cannot prevent root-level OS tampering before the telemetry hits the server. We fixed it at the galvanic layer.
Deterministic validation from instrument to ledger.
A deterministic, fail-to-wire network interceptor. It passively copies raw LC-MS telemetry at the physical layer. Zero latency introduced to the primary bus. Zero software installation required on the instrument PC.
Equipped with an independent Real-Time Clock and TPM, the node hashes telemetry the millisecond it leaves the instrument. Ground-truth data is established and chained before the Windows OS is ever involved.
Feed mathematically proven, untampered data into our enterprise AI agents. Detect anomalies in real-time and let Zyncra autonomously draft your FDA CAPA reports and deviation investigations if desired.
Zyncra was founded in Indianapolis to bridge the massive gap between modern cryptographic hardware and antiquated biopharma regulatory compliance. Software alone cannot solve root-level OS vulnerabilities.
Our architecture is built on deep domain expertise in mass spectrometry data pipelines, galvanic network isolation, and FDA 21 CFR Part 11 / ISPE GAMP 5 audit defense.
Because Zyncra operates as a passive, read-only hardware network tap, it is entirely decoupled from your validated Chromatography Data System (CDS). Monitor your lab and guarantee data integrity without triggering a massive re-validation of your existing instruments.
Submit Pilot Application