🛡️ ROI for VP of Quality
21 CFR Part 111. FSMA 204. DOT. All in One System.
Built around a proven QMS framework - every form, every workflow, every audit trail your team already knows. Designed for the regulatory environment you operate in, not adapted from a generic ERP.
289 migrations
340+ tables, built around a live production QMS framework
Auto-Stop
CCP abnormal finding automatically creates a nonconformance record and blocks the affected lot from shipping - enforced at the database level
2-Person
Two-person lot release enforced at the database level - first and second approver must be different users. No bypass. Per 21 CFR Part 111.
Your SOPs
Your full SOP library, organized, version-tracked, and securely accessible in Littoral™
21 CFR Part 111
Dietary supplements cGMP
FSMA 204
Food Traceability Rule CTEs
DOT 49 CFR
Compliant BOL PDF generation
FSVP
Foreign Supplier Verification
HACCP
CCP verification + auto-NC
SQF / BRC
Audit-ready documentation
Quality Workflow Suite
Every QMS workflow your auditor will look for
🔴
NCR / SCAR / CAPA / OOS Workflow
Full sequential quality event chain: Nonconformance, Supplier Corrective Action Request, CAPA, Effectiveness Review. Each stage has required fields, role-gated approvals, and automated sequential numbering.
Full Chain
⚖️
21 CFR Audit Trail
Every field edit, state transition, approval, and archive action writes an immutable audit log entry with before/after JSON, user identity (Azure AD), and UTC timestamp. Built to satisfy FDA electronic records requirements.
21 CFR 11 Aligned
🗺️
FSMA 204 Critical Tracking Events
Lot traceability from receiving (goods receipt with supplier lot number) through production (batch records with lot allocation) through shipping (BOL with lot numbers and quantities). Every CTE captured and queryable.
FSMA 204
📊
SOP Library
Your full SOP library - organized by document type and category, version-tracked, with SAS-URL secure downloads. Upload new versions, set effective dates, and maintain a living document library that's always current.
Version-Tracked
🔬
Gap Analysis via Sonar™
Use Sonar™ to analyze any prospect's or customer's SOP set against Littoral™'s workflow coverage. Identify gaps in their quality system before you commit to production - or help them close the gaps with your services.
Sonar™
📋
CoA with QA Approval Chain
Certificate of Analysis generated from captured test results. QA approval required before the CoA is finalized and made available in Harbor™. PDF stored in Azure Blob with SAS-URL access. Auto-delivered to customers on approval.
Auto-Delivered
Built for the regulatory environment you live in
We'll walk you through an end-to-end quality event - from CCP abnormal finding to CAPA closure - using your actual product categories.