365Phyta Core
Lot and status control, genealogy, cost per gram, a full audit trail and electronic signatures.
365Phyta for EU-GMP processors
Receiving bulk, decontamination, packaging and release as EU-GMP process orders on 365Forge, with executed batch records, QC per market, deviations and CAPA. A lot cannot be released with an open deviation or a missing test.
Available at launch
“Can I release this batch, and defend it in an inspection?”QP / Head of Quality
“Are the specs right for the market this lot is going to?”QC
“Does the stock book reconcile to the gram?”Compliance officer
Modules you would use
365Phyta Licensing
Licences and permits, counterparty qualification, a stock book to the gram with quotas and period close, and a destruction register with a witness who must be a different person from the one recording it.
365Phyta Quality (production on 365Forge)
Specifications, CoA verification, batch records, deviations, CAPA and QP release.
365Phyta Wholesale
GDP distribution with FEFO and released-only picking, market pricing and serialisation.
Regulations it is designed to support
EU-GMP Part I & II
Master and executed batch records, QC, deviations and CAPA as controlled records.
Annex 7 & 19
Herbal starting materials, and reference and retention samples linked to each lot.
Annex 11 & 15
Supports Annex 11 / Part 11 requirements such as audit trails and electronic signatures. Validation support available on request.
Annex 16
QP certification and batch release, blocked while deviations are open or tests are missing.
Questions processors ask
Can a QP release a lot with an open deviation?
No. Release is blocked while deviations are open or tests are missing. The QP certifies under EU-GMP Annex 16 with an electronic signature that shows who signed, when and with what meaning, as Annex 11 section 14 requires.
Do processors need Business Central Premium for production?
No. Production runs on 365Forge, our process-manufacturing app for Business Central Essentials, so no Premium licence is needed.
Can one product carry different specifications per market?
Yes. QC specifications are set per market, so one product can carry the limits and labels that Germany and Portugal each require.
Is validation documentation part of the Manufacturer bundle?
Validation support available on request. Under GAMP 5 you validate the system in your own environment, including performance qualification.
Further reading
365Phyta Quality: GMP manufacturing365Phyta Licensing: controlled substances365Phyta Wholesale: GDP distributionEU-GMP batch records and QP releaseAnnex 11 checklist for a cannabis ERPEU-GMP requirement by requirementValidation: who does whatAnnex 16 and QP release, definedEU-GMP vs US seed-to-sale