One record. Every capability.
Compliance, cold chain, clinical logistics, carriers, analytics and AI, attached to the same shipment record, behind the same audit trail.
Shipment lifecycle
One record from draft to delivered.
Every shipment moves through a server-enforced state machine, draft, submitted, compliance review, approved, shipped, delivered, with optional dual-approval and finance steps. Terminal states are immutable.
Role-aware intake
Material, destination, transport and category capture with fields your admin can hide, relabel or require.
Templates & cloning
Save recurring lanes as templates; repeat shipments take minutes, not forms.
Bulk CSV import
Per-row validation with precise error reporting for high-volume programmes.
Returns & recalls
Trial returns, damaged goods and Class I/II/III recalls linked to the original record.
Compliance & screening
Gates, not guidelines.
Compliance checks are enforced in the workflow, not documented beside it. A shipment cannot reach approval with a missing document, an unscreened party or an unresolved export-control flag.
Denied-party screening
Fuzzy matching (Levenshtein + token overlap) across OFAC SDN, OFAC Consolidated, BIS Entity & Denied, EU, UN and UK OFSI, refreshed nightly.
Corridor document gates
Origin/destination/material-class rules define required documents and block submission until they exist.
Export control
ECCN classification (EAR99, dual-use, munitions), export-licence logic and CITES permit workflows.
Dangerous goods
UN number and IATA packing-instruction reference data with auto-suggest.
Audited overrides
Officers can override a screening hit, with a mandatory reason that lands in the audit trail.
Evidence pack export
Audit CSV, e-signatures, generated documents, excursions and screening records in one bundle.
21 CFR Part 11
Signatures an auditor can verify.
Every workflow action, submit, approve, reject, ship, deliver, carries a two-component electronic signature whose SHA-256 hash binds it to the exact record state at signing time.
Two-component signing
Session token plus password re-entry on every signature, never reused (§11.200(a)).
Record-state binding
Integrity hash covers the full shipment state, signer, timestamp and meaning (§11.200(b)). Post-signature edits are detectable on read.
Dual-officer mode
When enabled, two distinct compliance officers must sign independently.
Append-only signature store
PostgreSQL triggers reject UPDATE and DELETE on the signature table.
Cold-chain intelligence
Know about the excursion before it happens.
Logger files flow in, stability budgets count down, and a multivariate model forecasts breach probability 6, 12 and 24 hours ahead, on a local model, with zero data egress.
Logger ingestion
Sensitech, Berlinger and generic CSV parsers with automatic excursion detection.
TAET stability budgets
Cumulative time-out-of-range per material, NOMINAL, ALERT, CRITICAL, EXHAUSTED, per ICH Q1A(R2) and Q5C.
Breach prediction
Risk forecast from temperature trend, lane history, ambient weather and transit time.
Deviation reports
GxP temperature-investigation PDFs generated from the excursion record.
Packaging guidance
Validated packaging recommendations by temperature range and transit time.
Hash-chained custody
Every handover hashes the previous entry, tamper-evident end to end.
Clinical trial logistics
Kit-level accountability, sponsor-level visibility.
IMP kits tracked through quarantine, dispatch, return and destruction, with reconciliation reports and CTMS sync, protocol numbers, sites and blinding status attached to every shipment.
IMP kit lifecycle
Full chain from quarantine to destruction with reconciliation reporting.
CTMS integrations
Veeva Vault, Medidata Rave, Oracle CTMS and FHIR R4, sites, protocol versions, order references.
Trial-aware records
Protocol, sponsor, investigator site, blinding status, patient count and visit number on the shipment.
Partner portals
Revokable, time-limited access for couriers, 3PLs, CROs and sites, per shipment, per role.
Carriers & cost
Carrier-neutral. Cost-aware.
Rate, book and track across seven carriers from one desk, match invoices against rate cards, and export approved freight spend straight into your ERP.
Live rates & booking
DHL, FedEx, UPS, World Courier, Marken, DPD and TNT via per-org carrier adapters.
Invoice variance flagging
CSV, email-parse, webhook or manual invoices matched against rate cards; overbilling above 5% is flagged.
Carrier scorecards
On-time rate, average transit time and DPS-clear rate, ranked per lane.
ERP export
Approved invoices flow to SAP FICO, Oracle AP, Sage, Xero, QuickBooks or a custom webhook.
Public tracking portal
Branded, token-secured consignee tracking with delivery e-signature and condition capture, no login required.
Cost allocation
Chargeback reports by cost centre, project, carrier and period.
Local-first AI
Inference inside the firewall.
Every regulated AI feature runs on Ollama in your cluster. Air-gapped installs make zero external calls; the optional cloud assistant is off by default.
Risk scoring
Each submission scored 1–10 with a plain-English rationale, stored on the record.
Customs enrichment
HS-code suggestions and customs descriptions drafted from material data.
Document drafting
Compliance document content drafted for officer review before generation.
Form assistance
Field suggestions from previous shipments, material type and destination.
Shipment optimisation
Consolidation, carrier-swap and cold-chain efficiency suggestions.
Regulatory intelligence
EMA, FDA and WHO alerts summarised into a feed your team can act on.
Analytics & reporting
Evidence-grade analytics.
Dashboards for operations, KPIs for compliance, and generated chapters for your Annual Product Review, all from the same records that carry the signatures.
Executive dashboards
Volumes, status mix, 30-day trends, top routes and carrier performance.
Compliance KPIs
Approval rate, time-to-approve, rejection rate, DPS clear rate, doc-gate blocks.
Scheduled reports
Weekly or monthly shipment summaries, compliance KPIs and audit digests by email.
APR/PQR transport chapter
Volumes, excursion summary, compliance rates and carrier performance per EU GMP Chapter 1.
Governed OData feed
Power BI / Tableau-ready, per-consumer API keys and rate limits, every query audit-logged.
Notifications
Status changes, compliance alerts, excursions and system events in one centre.
Warehouse & mobile
Built for gloves, scanners and low light.
A mobile PWA for cold-store workers and shipping supervisors: large touch targets, barcode input, single-purpose screens for ship-confirm, deliver-confirm, temperature log and excursion report.
Mobile PWA
Installable, offline-capable, dark-mode warehouse UI.
Scanner-first
Bluetooth barcode input on every lookup.
E-signatures on the dock
Part 11 signing extended to ship and deliver actions, on mobile.
Administration & deployment
Your cluster. Your rules. Your divisions.
Single-tenant Helm deployment with division-level scoping, white-label branding, configurable workflows and a migration engine for the history you bring with you.
Divisions & scoping
Hierarchies with per-division branding; users see only their division unless granted global access.
SSO & MFA
SAML 2.0 with signed assertions and replay protection; TOTP MFA with org-wide enforcement.
Workflow configuration
Dual compliance, finance step, SLA targets and step labels, configured, not customised in code.
Field customisation
Hide, relabel or require any shipment form field.
Data migration engine
Validated imports from CSV, Excel, SAP and Oracle OTM with dry-run, rollback and admin attestation.
GDPR tooling
Article 17 crypto-shred erasure and Article 20 portability exports, both audit-logged.
Want the compliance detail behind all of this? Read the trust & compliance page →
See it live in 25 minutes.
Eight guided flows: compliance review, DPS screening, Part 11 e-signature, custody chain, breach prediction, GDPR erasure and the validation report. Then a 90-day pilot on your own programme, fully creditable.