Cypher AI for Regulatory & Quality

Maintain audit-ready protocols, track sample chain of custody, and generate compliance reports without burning a quarter on documentation.

For teams operating under GxP, ISO, or regulatory submission requirements, R&D documentation is the dominant tax. Every change needs a record. Every signature needs a trail. Every protocol needs a version. The actual science is bottlenecked by the paperwork. Cypher AI takes the documentation work seriously — change tracking, chain of custody, and reporting are first-class features, not afterthoughts.

How Cypher AI helps regulatory & quality teams

One connected platform for the work you do today and the data you generate tomorrow.

Field-level audit trails on every entity

Every sample, protocol, request, and result tracks who changed what, when, and what the previous value was. Full audit logs for inspections.

Versioned protocols with electronic signatures

Protocols are versioned with effective-date tracking. Every run is bound to the specific protocol version it executed. Add e-signature workflows for review and approval gates.

Chain of custody for samples and materials

LIMS records every transfer, aliquot, and storage event. When a sample lands at QC, its full history — synthesis, transfers, freeze cycles, handlers — is one click away.

Standardized reports with AI assistance

Generate method reports, deviation reports, and submission-ready documents from structured Cypher data. The AI agent helps draft narrative sections; the underlying data is always traceable.

Role-based access with SSO and granular permissions

Enterprise SSO via SAML/OIDC. Permissions at project, file, and resource level so QA, R&D, and external auditors only see what they should.

Inspection-ready by default

1

Codify the protocol

A QA-approved protocol is published in Cypher with explicit version, materials, equipment, and acceptance criteria. Every subsequent run inherits that exact version.

2

Run and record

Operators execute the protocol in Cypher; deviations are flagged in real time and routed for review. Timers, calculations, and instrument readings are captured automatically.

3

Review and sign

A reviewer signs off through Cypher's e-signature flow. The signed run is locked, with full audit trail of any subsequent edit attempts.

4

Report and respond

When the auditor or regulator asks, every record is queryable, exportable, and traceable to its source. Response time drops from weeks to hours.

Stop trading scientific velocity for documentation overhead. Cypher gives you both.

Other use cases