SOLUTIONS · HEALTH & LIFE SCIENCES
Health and life sciences operators run two records on every shipment — commercial and regulatory — and they don't talk. QC says the lot ships. The datalogger flags an 8-hour excursion in Singapore. Reg affairs is renewing the UAE registration with a different SKU code. The recall risk lives in the seams. So does the audit failure. TradeOS holds the lot, the cold-chain telemetry, the regulatory chain, and the commercial order as one record. Built and run on EDMA Group's own glove distribution business across 9 countries — validated workflows for medical devices, disposables, IVDs, pharmaceuticals, and consumer health.
WHO THIS IS FOR
Health and life sciences spans medical disposables at $5M trade volume up to pharmaceutical APIs above $500M — held together by one thread. Non-compliance has consequences orders of magnitude beyond commercial loss: product recalls, FDA holds at customs, import refusal, license suspension. EDMA Group's own glove distribution business, across 9 countries, is the dogfood for everything on this page.
Class I / II / III devices, durable and capital equipment. FDA 510(k) / PMA, CDRH oversight, EU MDR, ISO 13485 quality system. UDI serialization required; engineering documentation overlaps with industrial B2B but compliance is the driver.
What's distinctEvery unit carries a UDI tied back to lot & design history file.
Gloves, masks, syringes, gowns, surgical instruments. Volume-based distribution from Asian factories to global health systems — the exact business EDMA Group runs every day across 9 countries. Every workflow on this page has been pressure-tested against real disposable gloves operations.
What's distinctLot economics live or die on container-level QC and country-of-destination filings.
Test kits, reagents, lab consumables, calibrators, controls. EU IVDR now fully in effect; FDA CDRH oversight in the US. Batch-specific quality control runs on every shipment; biologics-containing kits require active cold chain.
What's distinctCold chain is critical for biologics; batch QC must travel with the lot.
Finished drugs plus active pharmaceutical ingredients. DSCSA serialization in the US, EU FMD verification, GMP audits across the chain, MAH letter chains across every market. Annex 11 / 21 CFR Part 11 system validation is the floor.
What's distinctThe heaviest regulatory weight of the five — serialization down to the saleable unit.
OTC drugs, dietary supplements, nutraceuticals, vitamins. FTC claims compliance, FDA CFSAN oversight, GMP for dietary supplements (21 CFR Part 111). Lighter than pharma but still meaningful audit requirements — especially on health claims and label content.
What's distinctClaims compliance is its own audit surface, separate from the product.
COLD-CHAIN TEMP · 38D
LOT-2026-0418-A·
1,200 boxes · 240,000 pcs · sterile-eligible · batch QC pass
23 attributed events · cryptographic chain · replayable in 90s
RECALL READINESS
Trace this lot to every customer in one click.
14 health-system buyers · 27 jurisdictions · 240,000 pcs allocated.
≤ 90s
Counted from today, scoped to the jurisdictions this lot ships into
UAE MoH registration · renewal
MOH-DRG-2024-08-1142 · Legal AI draft ready
47
DAYS
Top Glove plant audit · ISO 13485
Annual surveillance · auditor: TÜV SÜD
22
DAYS
EU MDR DoC v.4 · on file
Valid through Sep 2027 · no action
514
DAYS
ANVISA registration
Valid through Jan 2028 · no action
622
DAYS
ATLAS · HEADS-UP
1 supplier audit due in 22 days on Top Glove Plant 04 — the source for this lot. Pre-audit pack assembled: 12 deviation logs, 4 change controls, training matrix. Ready for auditor portal.
THE PROBLEM
Health and life sciences fails differently from commodity distribution. Production sits in the supplier's QMS, cold-chain in the datalogger vendor's portal, QA in a validated CSV, documents in a regulatory drive. The seams are where holds, recalls, and lost lots come from — not in the product itself.
The datalogger captured it — 12°C for six hours. The forwarder didn't escalate. The customer's QA team finds out at receiving inspection. $200K lot quarantined, customer relationship strained, and the recall window starts ticking.
The format requirement changed two months ago. The supplier didn't know. The broker didn't catch it. The shipment is held at LAX customs for 18 days — $40K demurrage, missed PO deadline, and the operator's next quarter forecast goes red.
Production record in SAP. Cold chain in Loggit. QA in TrackWise. Documents in Veeva. EDMA reconstructs the full chain in under 90 seconds — every action, every signer, every datalogger reading, on one screen, cryptographically chained.
ONE WORKSPACE · LOT DETAIL
The lot is the operating unit in regulated trade. Open one and see its manufacturing data, its quality data, its cold-chain trace, its distribution chain, its regulatory filings, and its full audit log. Engineering and commercial documents on the same record, versioned together, signed off together — with recall-readiness as a first-class action.
MANUFACTURING DATA
QUALITY DATA · CoA / OOS / DEVIATIONS
COLD-CHAIN · SENSITECH TEMPTALE 4
REGULATORY DOCS · CHAINED TO LOT
DISTRIBUTION · 14 CUSTOMERS · 27 JURISDICTIONS
AUDIT LOG · LATEST EVENTS
PER-LOT ECONOMICS · COMPLIANCE COST
For regulated goods the cost stack is not just manufacturing + freight. Regulatory filing fees, QA review labor, cold-chain telemetry, and integration tax across four disjoint systems can add 4–7% to a lot. EDMA holds the entire chain on one record — the overhead drops by a measurable percentage point.
LOT-2026-0418-A · 240,000 pcs nitrile gloves · landed cost build-up
1MFG · FOB MY
Manufacturing cost
Top Glove Plant 04 · Klang MY
FOB BASIS
$92.7K
Manufacturer-side, pre-shipment
2FREIGHT · COLD-CHAIN
Cold-chain freight premium
Reefer container · Sensitech datalogger
COLD-CHAIN BAND
7.1%
Higher for IVDs / pharma biologics
3REG. FILINGS
Regulatory document fees
Per-jurisdiction filings amortized
FILING TAIL
2.6%
Spread across 27 jurisdictions
4QA · LABOR & STACK
QA review labor & integration tax
Where EDMA actually wins back margin
EDMA SAVINGS
−1.0%
Of landed · vs. legacy stack
NET LANDED · PER-BOX ROLL-UP
Atlas auto-traces 73% of QA review work. The integration tax across SAP + Loggit + TrackWise + Veeva goes to zero. On a 1,200-box lot that's $1,800 back; across 240 lots per year, $432K of compliance overhead reclaimed without touching the manufacturing side.
ANNUAL @ 240 LOTS
+$432K
Compliance overhead reclaimed
DOCUMENT CHAIN · REGULATORY + COMMERCIAL UNIFIED
Regulated trade layers regulatory documents on top of the standard commercial ones — FDA filings, CE DoC, GMP certs, ISO 13485, MAH letters, UDI, country registrations, DSCSA / FMD serialization, cold-chain certificates, deviation reports. EDMA tracks every required document by counterparty, by ship-to jurisdiction, by lot. No parallel folders, no parallel folders, no parallel folders.
CI commercial invoice · PL packing list · BL bill of lading · CO certificate of origin · CoA certificate of analysis · batch QC · GMP manufacturer GMP certificate · ISO ISO 13485 / 9001 quality system · FDA establishment reg. + prior notice · CE Declaration of Conformity · EU MDR / IVDR · MAH marketing authorization holder letter (pharma) · UDI unique device identifier · lot serialization · DSCSA serialization (US) / FMD (EU) · pharma only · COLD cold-chain datalogger trace + cert · DEV deviation / OOS reports if any · CTRY country registrations · UAE / TR / BR / AU / IN / ZA
WORKING CAPITAL
Health-system buyers in EU, GCC, LATAM, and ASEAN pay against documentary letters of credit. The lot doesn't release for payment until the document set matches the LC, the Incoterm, and the destination's regulatory requirements — EDMA's 5-layer document requirements engine tests every doc at presentation, not after.
LC PRESENTATION · FIRST-TIME-RIGHT
EDMA cross-tests every document against the LC terms, the Incoterm, the destination's regulatory profile, the lot's GMP status, and the operator's preferred bank. Discrepancies are flagged before paper goes to the issuing bank — not after the discrepancy fee lands.
PRE-SHIPMENT FINANCING · LOT-BACKED
Lot-backed financing reads from the live record — CoA signed, datalogger clean, FDA / CE filings current. Lenders bid against a lot, not a borrower. For dogfood disposables operations like EDMA Group's, that drops the cost of capital by 140–220 bps versus a generic supply-chain facility.
RETURNS, RECALLS & QUARANTINE RESERVE
Regulated lots carry a quarantine reserve (typically 2–5% of lot value) until the regulatory tail clears — final country acceptance, post-market surveillance window, customer complaint review. EDMA holds the reserve on the lot record and releases it when the audit conditions clear, not when accounting remembers.
PLATFORM FIT
Health and life sciences leans on a specific subset of EDMA — Documents for the 5-layer regulatory requirements engine, Production for lot + QC stage tracking, Manufacturers for GMP / ISO cert & audit calendar, Communications for cold-chain alerts. On the AI side, Legal AI drafts regulatory filings, Document Intelligence OCRs incoming certs, and Atlas reconstructs the audit chain. Portals are sub-segment specific.
DocumentsCORE
5-layer requirements engine for regulatory + commercial unified. OCR + structured field extraction for incoming CoAs, GMP certs, MAH letters; per-jurisdiction filing checklists generated from the lot record.
ProductionCORE
Lot tracking with QC stages, batch records, deviation reports, OOS handling. Sterilization cycles, calibration records, line-clearance checklists attached at the lot level — not in a separate QMS.
ManufacturersCORE
GMP / ISO 13485 cert tracking with expiry alerts. Audit calendar — annual third-party + internal — with auto-built audit packs (deviation log, change-control log, training matrix) for every visit.
CommunicationsCORE
Cold-chain alerts on WhatsApp / email / SMS to QA team the moment a datalogger reading breaches threshold. Translated to the recipient's language; ack required within 2h on critical excursions.
FinanceCORE
LC presentation with 5-layer doc check, lot-backed pre-shipment financing, recall reserves as first-class objects, quarantine holds tracked per lot. Validation pack (IQ/OQ/PQ) shipped per release.
Legal AIAGENT
Regulatory filings drafted from operational data — country registration applications, change-control letters, manufacturer quality agreements, MAH appointment letters. Trained on the operator side of the regulated table.
OCR-based extraction of incoming CoAs, GMP certs, MAH letters, batch records. Compliance gap detection: “This lot is missing the manufacturer’s batch record for jurisdiction X” — flagged at receiving, not at audit.
AtlasAGENT
Auditor portal queries: “Show every action on Lot-X during March” → reconstructed chain in < 90 seconds, attributed, time-stamped, cryptographically signed. Same answer the auditor would have built by hand in half a day.
Predictive AIPOST-LAUNCH
Forecasts regulatory changes by jurisdiction; flags lots at risk of new requirements. “EU IVDR scope extension lands in 90 days — 14 of your IVD lots become re-certification candidates.”
Bot StudioRULES
“When datalogger reading crosses limit, page QA on-call.” “When a country registration is < 60 days from expiry, draft renewal via Legal AI and queue for review.” Rules compose against the live lot record.
Supplier portal · manufacturers
GMP-rated facilities upload batch records, deviation reports, and cert renewals directly into the operator's QMS layer. Pre-built audit-pack publishing; change-control acknowledgement workflow built in.
Logistics portal · cold-chain carriers
Sensitech, Berlinger, ELPRO, Carrier CCS, Emerson Tagit push datalogger streams via API. Excursions auto-flag, lot status auto-moves to quality review, QA gets a Critical task in the same minute.
Client portal · health systems / hospitals
Download lot traceability reports on demand, search by lot or batch, request CoA / CoC retrieval. Reorder workflows for high-volume disposables; standing-order automation for IV solutions and consumables.
Auditor portal · read-only
Read-only role · pre-built audit packs · deviation log, change-control log, training records, datalogger archives. Atlas-driven free-text query: ask in English, answer cites the record.
Regulator portal · FDA / EMA / etc.
Inspection-ready dossier on demand: facility profile, audit history, recall record, post-market surveillance summary. Optional — pharma operators usually enable it; disposables operators sometimes do.
COLD-CHAIN MONITORED COUNTERPARTIES
Regulated trade is a network with two distinct verifications at every hop — the manufacturer's quality system and the destination's import authority. EDMA holds the whole graph as one object: GMP / ISO status on the supplier side, registration status on the destination side, cold-chain telemetry on every link in between.
ONE EVENT, FIVE EFFECTS
The cascade is the point. EDMA holds the datalogger stream, the lot record, the QA workflow, the customer-side notification, and the audit trail on the same record — so a cold-chain excursion propagates through every dependency in the minute it lands. No three-day lag to receiving inspection; no quarantined lot in the customer's freezer.
Total elapsed: under three minutes from the datalogger reading hitting 12°C to the QA on-call holding a Critical task with the trace, the CoA, and the customer notification draft on her phone. Without EDMA, the same chain runs through a Sensitech portal alert, a forwarder ignoring it, an SAP transit record, a TrackWise quality hold raised at receiving, and a customer email scramble three days later — and the $200K quarantine usually lands before any of it.
VS. THE WAY IT'S DONE TODAY
| Capability | TradeOS | Veeva Vault | TrackWise (Sparta) | MasterControl | SAP S/4 + GxP module | Spreadsheet + email |
|---|---|---|---|---|---|---|
| Lot-level traceability native (not configured) | ✓ | via doc binding | QMS-centric | QMS-centric | via custom dev | manual |
| Cold-chain telemetry embedded | ✓ | — | — | — | 3rd-party portal | — |
| Regulatory + commercial docs unified | ✓ | regulatory only | quality only | quality only | commercial only | two folders |
| Audit replay in seconds (not hours) | ≤ 90s | hours | hours | hours | days | days |
| 27-jurisdiction registration workflows | ✓ | RIM only | — | — | — | manual |
| Sub-segment coverage · devices / disposables / IVDs / pharma / consumer health | ✓ | pharma-first | pharma + devices | pharma + devices | generic | — |
| Validation pack · IQ / OQ / PQ per release | ✓ | ✓ | ✓ | ✓ | via consultant | — |
| 21 CFR Part 11 / EU Annex 11 native | ✓ | ✓ | ✓ | ✓ | configurable | — |
| DSCSA / FMD / UDI serialization · first-class | ✓ | add-on | — | add-on | configurable | — |
| Deploy time · first lot live | 4 weeks | 9–18 mo | 9–18 mo | 6–12 mo | 12–24 mo | today |
A QMS handles quality. A regulatory information management suite handles filings. An ERP handles the close. A datalogger portal handles temperature. None of them holds the lot as a record — with the cold-chain trace, the regulatory chain, the commercial doc set, and the audit trail under one ID. EDMA does, across all five regulated sub-segments — pressure-tested on EDMA Group's own glove distribution business across 9 countries.
FREQUENTLY ASKED
Yes. Validated audit trail with cryptographic chaining, electronic signatures, role-based access control, and time-stamped action logging on every record. IQ / OQ / PQ documentation is shipped per release; computer system validation pack is available under NDA before purchase. Validation pack travels with the operator's SOPs into their QMS.
Book a 30-minute walkthrough. We'll model one of your live lots — devices, disposables, IVDs, pharma, or consumer health — and show the manufacturing data, the cold-chain trace, the regulatory chain, and the audit replay on a single record.