Compliance for controlled substances, built into Business Central. Built for inspection, every day.
Narcotics and psychotropics, with medical cannabis as the flagship, from source to pharmacy. Licences and permits, a stock book to the gram, signed period close and released-only distribution, in one system.
Walk it room by room.
Five rooms on one route, from source to pharmacy. Each door opens only when its control is met, and every gram is kept in the stock book against the lot.
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01
Source
A controlled substance enters the chain under a licence: grown from mother plants and plant batches under GACP,2 or received from a qualified, licensed supplier under an import permit.1 Every gram is in the stock book from the first record.
Licence and permit checked
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02
Process
Drying, extraction, formulation and packaging run as process orders on 365Forge, with master and executed batch records.3 Inputs, yields and losses post to the stock book, so every difference is explained.
Batch record signed
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03
Test and release
Results are recorded against the specification, and an OOS or OOT result opens an investigation.4 A lot cannot be released while a deviation or CAPA is open or a test is missing. The QP certifies with an electronic signature.56
QP certification and e-signature
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04
License and ship
Before an order is released, the counterparty's qualification and licence, the permit balance and the quota are checked, and the controlled-substance officer signs off. Every movement posts to the stock book.
Licence, permit and quota checked
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05
Distribute
GDP distribution to wholesalers and pharmacies.8 Picking follows FEFO and takes released stock only. Packs carry SGTIN or SSCC codes and EPCIS events are exported.9 Anything destroyed is recorded with a witness.
Released stock only, FEFO pick
For the controlled-substance officer
Whether your title is narcotics officer or, for medical cannabis in Germany, responsible person under the MedCanG, licences, permits and quotas are checked before an order is released. The stock book reconciles to the gram for any period, and each period is closed with your signature.
For the Qualified Person
Specifications, results, deviations, CAPA and executed batch records in one place. A lot cannot be released with an open deviation or a missing test.
For the Responsible Person
Qualified customers, released-only FEFO picking, serialisation and recall, so what leaves the warehouse is what QA released, to a customer entitled to receive it.
What's different for controlled substances.
Nine controls built into the system, not left to procedure.
Licences and permits
A licence register and per-shipment import and export permits, with the remaining balance checked on every order.
365Phyta LicensingCounterparty qualification
Suppliers and customers are qualified, and their licences checked, before an order can be released.
365Phyta LicensingStock book to the gram
Every receipt, process use, sale, return and destruction posts to the stock book, which reconciles to inventory for any period.
365Phyta LicensingQuotas
Quotas are tracked against what you receive, make and ship, and checked before an order is released.
365Phyta LicensingPeriod close with e-signature
Each stock-book period is closed with an electronic signature and kept as signed.
365Phyta LicensingWitnessed destruction register
Every destruction is recorded against the lot, with a witness who must be a different person.
365Phyta LicensingRegulatory reporting
Reports to the authority come from the same stock book, not from a spreadsheet beside it.
365Phyta LicensingControlled-substance officer sign-offs
Regulated steps wait for the controlled-substance officer's electronic sign-off, with name, time and meaning recorded.
365Phyta LicensingReleased-only distribution
Only stock that QA has released can be picked and shipped, FEFO first.
365Phyta WholesaleMedical cannabis. From seed to signature.
Our flagship and most complete use case: cultivation, processing, import and distribution for licensed medical cannabis operators. Germany imported 201 tonnes of medical cannabis in 2025, up from 73 tonnes in 2024.10 Every kilogram crossed a border under two licences and an import permit, and was released by a Qualified Person.
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.
Install only what you need.
365Phyta is a set of Business Central apps on one core. Controlled substances start with Core and Licensing; medical cannabis adds Cultivation, Quality and Wholesale.
365Phyta Core
Lot and status control, holds, sampling, waste, a full audit trail, electronic signatures with re-authentication, and GS1 labels.
Every room365Phyta Licensing
Licences and permits, counterparty qualification, the controlled-substance stock book to the gram, quotas, period close with e-signature, the witnessed destruction register, regulatory reporting and controlled-substance officer sign-offs. For any narcotic or psychotropic substance.
04 License and ship365Phyta Cultivation
Mother plants, plant batches, input applications with pre-harvest intervals, environmental monitoring, harvest and grow log. The start of the medical cannabis chain.
01 Source365Phyta Quality
Specifications, sampling plans, results with OOS and OOT handling, CoA import and verification, equipment and line clearance, deviations and CAPA, master and executed batch records, QP batch release and recall.
02 Process, 03 Test and release365Phyta Wholesale
GDP distribution with FEFO and released-only picking, customer qualification, market pricing, SGTIN and SSCC serialisation, and EPCIS event export.
05 DistributeCountry packs In development
Separate extensions for each market, such as PZN and German pharmacy pricing rules in the Germany pack. Germany and Portugal are in development; more country packs planned.
Per market- Runs on
- Microsoft Dynamics 365 Business Central (SaaS). Essentials licences are enough; no Premium needed.
- Production: 365Forge
- Our process-manufacturing app for Business Central Essentials: recipes, process orders and costing.
- Warehouse: Vanguard WMS
- Warehouse operations on handhelds and terminals with the Vanguard WMS Mobile app.
Built for inspection, every day.
365Phyta is designed around the UN 1961 and 1971 conventions1 and around EU GMP and GDP. It supports Annex 11 and Part 11 requirements such as audit trails and electronic signatures.67 Under GAMP 511 you validate the system in your own environment; validation support is available on request.
Four controls the system enforces, whatever the procedure says.
Controlled-substance officer sign-offRegulated steps wait for the officer's electronic signature
EnforcedDestruction with a witnessThe witness must be a different person from the one recording it
EnforcedReleased-only pickingStock on quarantine, hold or rejected status cannot be picked
EnforcedE-signature with re-authenticationName, time and meaning at every regulated step
EnforcedBuilt for the strictest case: controlled substances.
The same apps support GMP manufacturing and GDP distribution for other medicinal products, controlled or not, including herbal and phytopharmaceutical products.
Manufacturing (GMP)
Specifications and sampling, CoA verification, OOS handling, master and executed batch records, deviations and CAPA, and QP release, with production on 365Forge.
Pharmaceutical manufacturingDistribution (GDP)
Customer qualification, FEFO and released-only picking, SGTIN and SSCC serialisation, EPCIS event export and recall.
Pharmaceutical distributionOne platform
365Phyta Core, Quality and Wholesale, the same apps that run the controlled-substance chain. Published pharma bundles: GDP Wholesaler at €149 and GMP Manufacturer at €289 per full user per month, all-in.
All solutionsCountry packs for Germany and Portugal.
Each market will be a separate extension with its own authority formats, codes and rules. Both packs are in development.
Germany
PZN and German pharmacy pricing rules, and BfArM permits for medical cannabis under MedCanG.14
In developmentPortugal
INFARMED requirements, including authorisations for medical cannabis under Decreto-Lei 8/2019.15
In developmentMore country packs planned. Tell us which market you supply.
Three ways to start.
Whether you run Business Central today or not.
Already on Business Central
Add 365Phyta to your tenant as apps. Essentials licences are enough, and you keep your Microsoft licences and partner.
Module-only pricesMoving to Business Central
We implement Business Central and 365Phyta together, as one project. The all-in price includes the Business Central Essentials licence.
All-in pricesStaying on another ERP Coming next
A standalone version of 365Phyta that connects to the ERP you already run. Tell us which system you use and we'll keep you posted.
Join the connector list
I've worked with Microsoft Dynamics NAV and Business Central for 15 years, on more than 70 projects in 13 countries, including pharmacy. Controlled substances run on the strictest rules in medicine: every gram licensed, counted and signed for. I built 365Phyta so a licensed operator can run all of it inside Business Central, from cultivation to the pharmacy shelf.Marius Teleman, Founder, Vanguard 360 Solutions LinkedIn
Questions.
More detail on the compliance page and in the glossary.
What is 365Phyta?
365Phyta is compliance software for controlled substances, built natively into Microsoft Dynamics 365 Business Central by Vanguard 360 Solutions. It covers licences and permits, counterparty qualification, a stock book to the gram, quotas, signed period close, a witnessed destruction register and released-only distribution. Medical cannabis is its flagship use case, and the same platform supports GMP manufacturing and GDP distribution for other medicines.
Which substances does 365Phyta cover?
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 controlled-substance 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 recorded?
In the destruction register, against the lot, with a witness who must be a different person from the one recording the destruction.
Can an order be released without a licence, permit balance or quota?
No. An order cannot be released unless both parties hold a valid licence, the permit balance is enough and the quota allows it.
Is 365Phyta only for controlled substances?
No. It is built for the strictest case, controlled substances, and the same platform (365Phyta Core, Quality and Wholesale) supports GMP manufacturing and GDP distribution for other medicinal products, controlled or not.
Which rules is 365Phyta designed around?
The UN Single Convention on Narcotic Drugs (1961) and the Convention on Psychotropic Substances (1971), EU GMP Part I and II with Annexes 11, 15 and 16, GDP (2013/C 343/01), and GACP for medical cannabis. It supports Annex 11 and Part 11 requirements such as audit trails and electronic signatures.
Is 365Phyta validated?
Under GAMP 5 the regulated company validates a computerised system in its own environment, so no vendor can sell a pre-validated system. Validation support is available on request.
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.
Does 365Phyta need Business Central Premium?
No. Production runs on 365Forge, our process-manufacturing app for Business Central Essentials, so no user needs a Premium licence.
Which countries does 365Phyta support?
Country packs for Germany and Portugal are in development, each with its own authority formats, codes and rules. More country packs are planned.
How much does 365Phyta cost?
Controlled-substance bundles start at €209 per full user per month all-in, including the Business Central Essentials licence on a 3-year term, or €160 for the modules only. Pharma bundles for non-controlled medicines are €149 (GDP Wholesaler) and €289 (GMP Manufacturer) all-in. See the pricing page.
Two design partners. One in Germany, one in Portugal.
We are looking for our first two customers: licensed operators handling controlled substances, one in Germany and one in Portugal. You get design-partner pricing, fixed for the first contract term, and we set up your licences, permits, stock book and batch records with you. In return we ask for regular feedback and, once you are live, a reference.
References
"Designed around" and "designed to support" are deliberate: a system supports compliance; your quality system and your validation make you compliant.
- UN Single Convention on Narcotic Drugs, 1961, and Convention on Psychotropic Substances, 1971: licences, records, estimates and import and export authorisations.
- EMA, Guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin.
- EudraLex Volume 4, EU-GMP Part I, Chapter 4: documentation, specifications and batch records.
- EU-GMP Part I, Chapter 6: quality control, including the investigation of out-of-specification results.
- EU-GMP Annex 16: certification by a Qualified Person and batch release.
- EU-GMP Annex 11, computerised systems: § 9 audit trail, § 14 electronic signatures.
- US FDA, 21 CFR Part 11: electronic records; electronic signatures.
- Guidelines on Good Distribution Practice, 2013/C 343/01.
- GS1 EPCIS and the GS1 identification keys GTIN/SGTIN and SSCC.
- BfArM data via StratCann: 201,094 kg of medical cannabis imported into Germany in 2025 vs 72,850 kg in 2024, by country of origin.
- ISPE GAMP 5: risk-based approach to GxP computerised systems. See the glossary.
- EU-GMP Annex 15: qualification and validation.
- ALCOA+ data integrity: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available. See the glossary.
- § 4 and § 12 MedCanG: operator permit and per-shipment import authorisation from BfArM.
- Decreto-Lei n.º 8/2019, applied by INFARMED.
See it in Business Central.
A 30-minute walkthrough of a controlled-substance lot, from the licence check to the signed stock-book close, with time for your questions. No slides.