Quality Module

Batch records and lot release that hold up in any audit

Every step from raw material receiving to finished lot shipment is timestamped, signed, and stored. When an auditor asks to see the record for a lot from 18 months ago, you pull it in 30 seconds.

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What quality covers

The full record from receiving to release

21 CFR Part 117 requires a complete, legible, dated, and signed record for every lot. Littoral makes that requirement automatic rather than aspirational, from HACCP hazard analysis and food defense through recall management and environmental monitoring.

Batch Records
Electronic batch records built around your manufacturing steps. Each step is signed, timed, and sequenced. No paper, no illegible handwriting, no missing pages.
Lot Release Checklists
Configurable release checklists that gate the release status of a finished lot. Every check requires a real user signature and a timestamp. Incomplete checklists block release automatically.
CoA Intake
Certificates of analysis attached to incoming raw material lots automatically, via AI email parsing or manual upload. Every CoA linked to the lot it covers, retrievable in seconds.
Deviation Management
Every deviation opened, assigned, documented, and closed in a traceable record. CAPA links, disposition records, and regulatory hold flags included. No deviation is ever lost in a shared inbox.
Non-Conformance Investigations
Structured investigation records with root cause categories, corrective action tracking, and effectiveness review. Built for SQF and GFSI audit expectations.
Traceability
One-click forward and reverse traceability from any raw material lot to every finished unit it touched, and from any finished unit back to every ingredient lot used. Complete in under 60 seconds.
HACCP and Food Defense
Hazard analysis and critical control point limits tied directly to batch records, with automatic out-of-limit flagging. Food defense vulnerability assessments track mitigation strategies and monitoring logs alongside the same audit trail.
Recall Readiness
Health hazard evaluation, effectiveness checks, and customer notification tracking built into the recall record. Environmental monitoring (temperature, water, compressed air) and equipment calibration with out-of-service tagging feed the same system a recall would draw from.
The audit trail

Every action. Every user. Every timestamp.

The Littoral audit trail captures the full who, what, and when for every record touched in the system. User ID, action type, before and after values, and a UTC timestamp. Tamper-evident by design.

GMP regulations require that records be prepared at the time of performance. Littoral enforces this: you cannot back-date a batch step, post-sign a deviation, or release a lot without a valid current user signature. The system is the control.

Audit log · Lot NS-2026-0412
07:14:32
Receiving record created R. Lopez · Weigh-In Step 1
07:18:04
CoA attached and matched AI intake · Lot match confirmed
09:42:17
Batch record step 3 signed M. Garcia · Blending completed
14:05:50
Lot released R. Lopez · All checks passed

Walk into your next audit with a complete record

See how Littoral quality management works for a toll manufacturer your size.

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