Unified Data Layer · Biomedical Logistics

Your cold chain data shouldn't live in 12 systems.

Virginia Data Sciences is the unified data platform for biomedical logistics — connecting cold chain sensors, DSCSA serialization records, and legacy ERP data into one audit-ready dashboard. Know about temperature excursions before shipments are ruined, not after.

⚠ DSCSA Nov 2024 deadline ⚠ FDA audit anxiety ⚠ Fragmented ERP data
DSCSA-Ready
CFR Part 11 Compliant
Real-Time Cold Chain
Cold Chain Monitor
LIVE
Lane A · Chicago ORD
2.4°C
✓ Within spec (2–8°C)
Lane B · Memphis MEM
9.1°C
⚠ Excursion detected
Lane C · Dallas DFW
3.8°C
✓ Within spec (2–8°C)
Lane D · Newark EWR
5.2°C
✓ Within spec (2–8°C)
DSCSA Serialization Coverage
94%
847
Active Lots
1
Excursion
100%
Audit Ready

Designed for
DSCSA
CFR Part 11
GDP
Cold Chain
Serialization
ISO 13485

Free · No Obligation · 48-Hour Turnaround

Get a Free DSCSA Compliance Assessment

Find out exactly where your serialization coverage gaps are — before an FDA audit does. No pitch, just an honest readiness score and a roadmap to close the gaps.

Assessment request received.

We'll reach out within 1 business day with your compliance readiness snapshot.

Platform Pillars

One platform. Every data source your operation depends on.

Biomedical logistics runs on data spread across sensors, ERPs, and compliance systems that were never designed to talk to each other. Virginia Data Sciences is the translation layer.

🌡️

Cold Chain Visibility

Real-time temperature and humidity monitoring across every shipment, every lane, every sensor — unified in one dashboard. Know about excursions the moment they happen, not when a shipment arrives spoiled at a hospital dock.

Real-time sensors Excursion alerts Chain of custody GDP compliance
📋

DSCSA & CFR Part 11 Compliance

Automated audit trails, electronic signatures, and serialization tracking built to the DSCSA Enhanced Drug Distribution Security standards. When an FDA inspector walks in, your data is already organized the way they want to see it.

DSCSA EDDS CFR Part 11 Audit trails E-signatures
🔗

Legacy ERP Integration

Works with Epic, SAP, Oracle, and your other existing systems. Virginia Data Sciences is a data layer, not a replacement — we pull and normalize records from your current infrastructure without forcing a rip-and-replace migration that disrupts operations.

Epic SAP Oracle HL7 / FHIR
🚨

Predictive Excursion Alerts

Machine learning models trained on historical cold chain and logistics data flag anomalies before they become excursions. Catch a failing reefer unit 90 minutes before it pushes a shipment out of spec — not after your product is compromised.

Predictive ML Anomaly detection Proactive alerts Risk scoring

Connected in days, not months.

Most "data integration" projects take 12–18 months and require an SI engagement. Virginia Data Sciences connects to your existing systems through standard APIs and certified connectors — without touching your core infrastructure.

01

Compliance Gap Assessment

We map your current data sources, identify DSCSA and cold chain coverage gaps, and score your serialization readiness against FDA requirements.

02

Data Source Integration

Connect ERP systems, cold chain sensors, TMS platforms, and serialization databases through our certified connector library. No custom development required for standard systems.

03

Unified Dashboard & Audit Trails

Your unified view goes live with pre-built DSCSA compliance reports, cold chain monitoring dashboards, and CFR Part 11-compliant electronic records ready for inspection.

04

Continuous Monitoring

Ongoing anomaly detection, automated compliance reporting, and model retraining as your logistics network evolves. Your compliance posture improves over time without manual effort.


See your DSCSA readiness score — before you're audited.

Upload a sample of your current serialization data (or describe your stack) and we'll send you a personalized compliance gap analysis. Covers DSCSA EDDS, CFR Part 11, and cold chain traceability. No cost, no obligation.

Get Your Free Compliance Gap Report

Tailored to your operation. Delivered within 1 business day.

📋

Gap report on its way.

Check your inbox within 1 business day. We'll also include a quick-wins checklist.

No spam. Unsubscribe any time.

Platform Pricing

Right-sized for your operation, not your IT budget's worst nightmare.

Every tier includes DSCSA audit trails, cold chain monitoring, and ERP connectors. You pay for scale and support level — not for compliance features that should come standard.

Starter
$149
per month
  • Up to 500 serialized lots
  • Cold chain dashboard (read-only sensors)
  • Basic DSCSA audit trail export
  • 1 ERP data connector
  • Community support
Get Started
Professional
$499
per month
  • Up to 5,000 serialized lots
  • Real-time cold chain monitoring
  • Full DSCSA EDDS compliance suite
  • 3 ERP connectors (Epic, SAP, Oracle)
  • Predictive excursion alerts
  • Email support
Get Started
Enterprise+
$1,999
per month
  • Everything in Enterprise
  • HITRUST CSF-aligned controls
  • Custom compliance reporting
  • Dedicated compliance analyst
  • SLA-backed uptime guarantee
Get Started
Managed
Managed Services
$2,495
per month
  • Everything in Enterprise+
  • We run your compliance ops
  • On-call data engineering support
  • Custom ERP integration builds
  • FDA audit response team
  • Weekly executive briefings
Talk to Us
Full pricing ladder:
Starter — $149/mo
Professional — $499/mo
Enterprise — $999/mo
Enterprise+ — $1,999/mo
Managed — $2,495/mo

Still running compliance on spreadsheets and hope?

Most biomedical logistics directors know their data is fragmented — they just don't know what it would take to fix it. A 30-minute conversation with our team will show you exactly where your gaps are and what unifying your data would actually cost. No pitch. No 80-slide deck.

DSCSA readiness scored against FDA guidance
Cold chain gap analysis included at no cost
Integration complexity assessed for your specific ERP stack
Response within 1 business day — no automated sequences

Request a Free Compliance Consultation

Tell us about your operation — we'll take it from there.

Request received.

A member of our team will reach out within 1 business day. Check your inbox for a confirmation.

No spam, ever. We'll only reach out about your consultation.

Your next FDA audit shouldn't be a surprise.

Virginia Data Sciences gives biomedical logistics teams a single source of truth for cold chain data, DSCSA serialization records, and ERP inventory — so compliance is a status report, not a fire drill.

Explore the Platform →