365Phyta Core
Lot and status control, holds, sampling, waste, a full audit trail, electronic signatures with re-authentication and GS1 labels.
Controlled substances on Business Central
For companies that grow, make, hold or trade narcotics and psychotropics, with medical cannabis as the flagship. Licences and permits, counterparty qualification, quotas, a stock book to the gram, signed period close, a destruction register with witnesses and released-only distribution, in the ERP you already run.
“Does the stock book reconcile to the gram for this period?”Narcotics officer
“Does the customer's licence cover this substance, and is the quota enough?”Compliance
“Who witnessed this destruction?”Inspector
What the rules ask, and what the system does
Licences on both sides
An order cannot be released unless both parties hold a valid licence for the substance, and counterparties are qualified before they are used.
Import and export authorisations
Per-shipment permits and their remaining balance are checked before an order is released.
Quotas
Quotas are tracked against what you receive, make and ship, and checked before an order is released.
Records of every movement
Every receipt, process use, sale, return and destruction posts to the stock book, which reconciles to the item ledger to the gram.
Period close
Each period is closed with an electronic signature, and the closed period is kept as signed.
Destruction
Every destruction is recorded in the destruction register against the lot, with a second witness who must be a different person.
Narcotics-officer sign-off
Regulated steps wait for the narcotics officer's electronic sign-off, with name, time and meaning recorded.
Reporting and distribution
Regulatory reports come from the same stock book, and only released stock can be picked and shipped.
Medical cannabis, the flagship
Medical cannabis is the most complete use case: cultivation from mother plant to harvest, processing, import and distribution, with four published bundles. Medical cannabis in detail.
GACP cultivators
Growing and exporting dried flower to EU-GMP processors.
EU-GMP processors
Receiving bulk, decontaminating, packaging and releasing.
Importers and wholesalers
Holding narcotics licences and supplying pharmacies.
Vertically integrated producers
Growing, processing and exporting within one group.
Modules you would use
365Phyta Licensing
Licences and permits, counterparty qualification, the stock book to the gram, quotas, signed period close, the destruction register with witnesses, regulatory reporting and narcotics-officer sign-offs.
365Phyta Cultivation
Mother plants, plant batches, input applications with pre-harvest intervals, environmental monitoring, harvest and grow log: the start of the medical cannabis chain.
365Phyta Quality
Specifications, sampling plans, OOS and OOT handling, CoA verification, line clearance, deviations and CAPA, master and executed batch records, QP release and recall.
365Phyta Wholesale
GDP distribution, FEFO and released-only picking, customer qualification, market pricing, SGTIN and SSCC serialisation, EPCIS event export.
Country packs (in development)
Separate extensions per market: Germany (including PZN and German pharmacy pricing rules) and Portugal are in development. More country packs planned.
Not in scope
Sterile or aseptic manufacturing, connection to the EU FMD / EMVS hub, pharmacovigilance, clinical-trial management, retail point of sale and patient data. We say so up front, so you can plan the systems around 365Phyta.
Questions
Is 365Phyta Licensing only for cannabis?
No. It applies to any narcotic or psychotropic substance handled under licence. Medical cannabis is the most complete case, with cultivation, processing, import and distribution.
Does the stock book reconcile to inventory?
Yes. The stock book reconciles to the item ledger to the gram, for any period, and each period is closed with an electronic signature.
How are destructions witnessed?
Every destruction is recorded against the lot with a second witness, who must be a different person from the one recording it.
Can an order be released without enough permit balance or quota?
No. A sales or purchase order cannot be released without valid licences on both sides, enough permit balance and quota.
Which national reporting formats are covered?
Country packs for Germany and Portugal are in development. More country packs are planned.
What does 365Phyta not do?
It does not cover sterile or aseptic manufacturing, connect to the EU FMD or EMVS hub, handle pharmacovigilance or manage clinical trials. It has no retail point of sale and holds no patient data.
Further reading
Medical cannabisGermany import permit, step by stepCountry packsCompliance, requirement by requirementPharmaceutical distribution (GDP)
See a stock book close in Business Central
30 minutes, from a licence and quota check on an order to a witnessed destruction and a signed period close.