Guide
EU-GMP medical export vs US seed-to-sale.
Side by side
| Dimension | US state seed-to-sale | EU medical export chain |
|---|---|---|
| Who you answer to | State cannabis regulators | National medicines and narcotics authorities (e.g. BfArM, INFARMED) and GMP inspectors |
| Unit of control | Tagged plants and packages reported to a state traceability system | Batches and lots with master and executed batch records |
| Release decision | Passing state-mandated testing | Certification by a Qualified Person under EU-GMP Annex 16 |
| Quality system | Testing and labelling rules | Full GMP quality system: deviations, CAPA, change control, validation |
| Cross-border trade | Built for sale within one state | Licences on both sides plus per-shipment import and export authorisations |
| Customer | Licensed retail dispensaries and consumers | Wholesalers and pharmacies, on prescription; GDP distribution |
| Electronic records | State reporting integrations | Audit trail and electronic signatures under Annex 11 and Part 11, validated under GAMP 5 |
| Typical ERP add-ons | Point of sale, loyalty, excise tax | Stock book, permit balances, QP release, retention samples |
Why it matters when you choose software
Most cannabis ERPs were designed in the US, where many states require licensees to report every plant and package to a state traceability system, and sales run through dispensaries. Those systems are good at tags, state reporting and retail. They were not designed for what an EU-GMP site is inspected on.
An operator exporting to Germany, or processing for it, is judged on different evidence: a batch record that shows each step was done as approved; a QP certification that cannot happen while a deviation is open; an import authorisation with enough balance for the shipment; and a stock book that reconciles to the gram. If the ERP does not hold that evidence, it ends up in spreadsheets and paper binders, which is where inspection findings start.
What stays the same
Both worlds need lot genealogy from plant to product, inventory accuracy and cost per gram. A medical ERP should do these as well as any seed-to-sale system, and connect them to the quality and narcotics records.
10 questions to ask any cannabis ERP vendor
- Can a QP release a batch in the system, with an electronic signature?Look for release blocked by open deviations or missing tests, and a signature that shows name, date, time and meaning.
- Does the system link cultivation records to batch records?GACP data should flow into the processing batch without re-keying, so genealogy is unbroken.
- How are per-shipment import and export authorisations handled?The system should refuse an order without valid licences on both sides and block quantities above the authorisation balance.
- Does the stock book reconcile to the item ledger for any period?Authorities ask for a period; the answer should not need a spreadsheet.
- What validation documentation do you provide?Expect IQ/OQ scripts and a requirements traceability matrix; you still own PQ.
- Are specifications set per market?Germany and Portugal can require different limits and labels; one product may need several specs.
- How is cost per gram calculated?Labour, inputs, energy and processing should roll up per lot, by strain, room and cycle.
- Do floor staff need full licences?Shared-device licences keep cultivation teams affordable.
- What is out of scope?A medical-only system should say plainly that it does not do retail POS, adult-use or patient data.
- What happens when a regulation changes?Market rules should live in country adapters, updated as data, not as a rebuild.
Where 365Phyta fits
365Phyta was designed around the EU medical rulebook from the start: GACP, EU-GMP and Annex 11, narcotics permits in Germany and Portugal, and GDP distribution, on Microsoft Dynamics 365 Business Central Essentials. It deliberately leaves out retail POS, adult-use and patient data. See pricing or the product brief (PDF).
Ask us the ten questions.
In a 30-minute demo we answer each one in the system, not on a slide.