365Phyta Core
Lot and status control, holds, sampling, waste, a full audit trail, electronic signatures with re-authentication and GS1 labels.
Pharmaceutical distribution (GDP)
Built for the strictest case: controlled substances. The same platform supports GMP manufacturing and GDP distribution for other medicines. For pharmaceutical wholesalers and distributors working to GDP, controlled or not: qualified customers, released-only FEFO picking, market pricing, SGTIN and SSCC serialisation, EPCIS event export and recall.
“Can anything leave the warehouse that QA hasn't released?”Responsible Person
“Is this customer entitled to receive this product?”Sales and Responsible Person
“Which customers received this batch?”Quality, recall
What GDP asks, and what the system does
GDP Chapter 5: customers
Customers are qualified before they are supplied, and an order to an unqualified customer cannot be released.
GDP Chapter 5: suppliers
Suppliers are qualified as counterparties, with their authorisations kept against the record.
GDP Chapter 5: storage
Picking follows FEFO and takes released stock only. Quarantined, held and rejected stock cannot be picked.
GDP Chapter 6
Returns and recalls are traced by batch to every customer who received it.
GDP Chapters 3 and 4
Supports audit trails and electronic signatures on the records GDP requires you to keep.
GS1 serialisation
Packs and logistic units carry SGTIN or SSCC codes, and EPCIS events are exported to your partners.
Modules you would use
365Phyta Wholesale
GDP distribution, FEFO and released-only picking, customer qualification, market pricing, SGTIN and SSCC serialisation, EPCIS event export.
Vanguard WMS
Warehouse operations on handhelds and terminals with the Vanguard WMS Mobile app.
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.
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
Can quarantined or rejected stock be picked?
No. Picking follows FEFO and takes released stock only. Stock on quarantine, hold or rejected status cannot be picked, whatever the order says.
Does 365Phyta connect to the EU FMD / EMVS hub?
No. 365Phyta assigns SGTIN and SSCC codes and exports EPCIS events for your own traceability and your partners, but it does not connect to the EU FMD / EMVS hub.
Can warehouse staff work on handhelds?
Yes. Vanguard WMS runs warehouse operations on handhelds and terminals with the Vanguard WMS Mobile app.
Do we also need Licensing?
Only if you distribute narcotics or psychotropics. 365Phyta Licensing adds licence, permit and quota checks and the controlled-substance stock book.
Does it handle German pharmacy pricing?
The Germany country pack, in development, will add PZN and German pharmacy pricing rules. Market pricing for other markets is set in 365Phyta Wholesale.
Further reading
Controlled substancesCountry packsRequirement by requirementGlossary
See an order picked and shipped under GDP
30 minutes, from customer qualification to a released-only FEFO pick and an EPCIS event, with your questions.