Every custody handoff checked automatically against its GDP-required temperature range — an excursion is flagged the moment it happens, not discovered on a quarterly audit. FSMA 204 Critical Tracking Events captured at every harvesting, cooling, packing, shipping, receiving, and transformation step. 21 CFR Part 11 electronic signatures with automatic witness-flag consistency enforcement, and an immutable audit trail for every regulated change.
Every user journey, the dashboard, and the AI Management Console — walked end to end.
A single platform for pharma and biologics QA teams — connecting products, batches, trading partners, custody transfers, temperature logs, electronic signatures, audit trail entries, quality releases, and deviation reports across the full regulated supply chain.
VPs of Quality Assurance, Compliance Officers, and Regulatory Affairs teams at pharma/biologics manufacturers, distributors, and pharmacies.
QA and regulatory staff manage products, batches, Critical Tracking Events, custody transfers, temperature logs, and quality release decisions — unlimited users, no per-seat cost.
The VP of QA or Compliance Officer queries batch status, temperature excursions, and deviation trends in plain English.
Purpose-built data models, workflows, and views — generated by the VeloIQ™ framework and refined for the vertical.
Pharmaceutical, biologic, vaccine, and perishable products with storage temperature requirements and cold-chain flags.
Batches and their Critical Tracking Events — harvesting, cooling, initial packing, shipping, receiving, and transformation — with Traceability Lot Codes.
Trading partners and custody transfers between them, with continuous temperature logging checked automatically against each transfer's required range.
Approval, witness-verification, and release signatures with automatic flag-consistency enforcement, plus an immutable audit trail of every regulated change.
Batch disposition (released, rejected, quarantined, recalled) tied directly to the electronic signatures that authorized it.
Severity-scored deviation investigations that auto-escalate to critical the moment they cross a risk threshold.
VeloIQ™ Pharma GDP & Traceability Matrix ships as a complete, working application — not a template you still have to build.
Arrives with realistic sample data (8 trading partners, 6 products, 12 batches, 52 Critical Tracking Events, 24 custody transfers, 72 temperature logs) plus a clean production-ready database. Explore instantly, then switch when you go live.
5 pre-configured NL chats with 24 sample sentences — batches & traceability, temperature & custody compliance, and quality & 21 CFR Part 11 compliance (native), plus batch-risk and Part 11 readiness AI assistants (agentic).
One veloiq run and the full application is live: REST API, React frontend, admin back-office, and AI console — all on your own infrastructure.
Automated smoke, regression, and licensing suites ship with the app, including checks that every temperature log's excursion flag matches its custody transfer's required range and that auto-escalation rules actually fired.
Measurable outcomes for every role — from the QA reviewer to the Compliance Officer.
Every temperature log is checked against its custody transfer's required range automatically — a compromised batch is flagged in transit, not at the next audit.
A signature marked "witness verification" must carry the witness flag — the system enforces the dual-person rule, not a checklist someone might skip.
Critical Tracking Events and Traceability Lot Codes are captured at every step — a full FSMA 204 trace is one query away, not a week of document requests.
Deviations scoring 4 or higher auto-escalate to critical severity the moment they're logged — the QA team never has to notice on their own.
Trading partners with a poor on-time delivery rate automatically lose their GDP-certified flag — certification status reflects real performance, not a stale annual review.
IQVigilant's Exception Management watches for the highest-consequence conditions — temperature excursions, critical deviations — with a 1-user free-tier license included.
From the batch dashboard to custody transfers, temperature logs, and deviation workflows — every screen generated by VeloIQ™, refined for pharma GDP compliance.
Ask questions in plain English. Get bar charts, pie charts, donuts, bubble charts, area charts, and boxplots — no SQL required. 5 pre-built NL chats for batches & traceability, temperature & custody compliance, and quality & 21 CFR Part 11 compliance (native), plus batch-risk and Part 11 readiness AI assistants (agentic).
Data models and metadata that speak your industry’s language — because compliance and interoperability start with the schema. See the full mapping in the app's STANDARDS.md.
| Area | Standard | Models mapped |
|---|---|---|
| Chain-of-custody & excursion monitoring | GDP | TradingPartner, CustodyTransfer, TemperatureLog (is_excursion, excursion_delta_c auto-derived) |
| Food/drug traceability & Critical Tracking Events | FSMA 204 | Batch, CriticalTrackingEvent (cte_type, traceability_lot_code) |
| Electronic records & signatures | 21 CFR Part 11 | ElectronicSignature (witness-flag consistency enforced), AuditTrailEntry, QualityRelease |
Every VeloIQ™ vertical application is versioned source code — not a locked SaaS. Fork, extend, integrate, or white-label.
Each module is a self-contained VeloIQ™ unit with its own models.py, generated GUI views, and REST API. Add or remove modules as your needs evolve.
Bring in IQVigilant for NL analytics and exception alerts, and Advanced Development for page-config templates, business rules, and data import — configured declaratively in veloiq.toml.
Add custom business logic in custom_api.py, override page-config templates per model:action, or add SQLAdmin views for advanced administration.
Switch from the shipped SQLite to PostgreSQL, MySQL, or Snowflake with a single connection string change. Schema migrations are tracked via Alembic.
AI-ready with 1-User Natural Language · 10 Exception Alerts · UI Configuration, Dynamic Business Rules & Data Import — learn about IQVigilant capabilities
Get in touch with the VeloIQ™ team to discuss deployment, customization, and licensing.