365Phyta Core
Lot and status control, holds, sampling, waste, a full audit trail, electronic signatures with re-authentication and GS1 labels.
Pharmaceutical manufacturing (GMP)
Built for the strictest case: controlled substances. The same platform supports GMP manufacturing and GDP distribution for other medicines. For manufacturers of medicinal products and APIs working to EU GMP, controlled or not, including herbal and phytopharmaceutical products: specifications, sampling, OOS handling, batch records, deviations, CAPA and QP release, with production on 365Forge.
“Can I release this batch, and defend it in an inspection?”Qualified Person
“Was every out-of-specification result investigated before release?”Head of Quality Control
“Can we show who changed this record, when and why?”QA, data integrity
What the rules ask, and what the system does
EU-GMP Chapter 4
Specifications, master batch records and executed batch records are controlled records, versioned and signed.
EU-GMP Chapter 5
Equipment status and line clearance are checked and signed before a production or packaging step starts.
EU-GMP Chapter 6
Results are recorded against the specification. An OOS or OOT result opens an investigation that must be closed before release.
EU-GMP Chapter 1
Deviations and CAPA are linked to the batch, and an open one blocks release.
Annex 16
QP certification with an electronic signature, blocked while a deviation, CAPA or test is open.
Annex 11 and Part 11
Supports Annex 11 / Part 11 requirements such as audit trails and electronic signatures with re-authentication.
EU-GMP Chapter 8
A recall traces every batch forward to customers and back to the materials it was made from.
Incoming materials
Supplier CoAs are imported and verified against your specification; materials stay in quarantine until QA changes their status.
Modules you would use
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.
365Forge (production)
Our process-manufacturing app for Business Central Essentials: recipes, process orders and costing, with no Premium licence needed.
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 a batch be released with an open deviation?
No. Release is blocked while a deviation or CAPA is open or a test is missing. The QP certifies with an electronic signature that shows who signed, when and with what meaning, designed to support EU-GMP Annex 16 and Annex 11 section 14.
How are out-of-specification results handled?
An OOS or out-of-trend result opens an investigation against the batch. The batch stays unreleased until the investigation is closed and signed.
Do we need 365Phyta Licensing?
Only if you handle narcotics or psychotropics. For other medicines, Core and Quality are enough.
Do we need Business Central Premium for production?
No. Production runs on 365Forge, our process-manufacturing app for Business Central Essentials, so no user needs a Premium licence.
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.
Does 365Phyta support sterile or aseptic manufacturing?
No. Sterile and aseptic manufacturing, pharmacovigilance and clinical-trial management are out of scope.
Further reading
EU-GMP batch records and QP releaseRequirement by requirementAnnex 11 checklistControlled substancesAnnex 16 and QP release, defined
See a batch released in Business Central
30 minutes, from goods receipt to QP certification, with a Business Central consultant who knows GMP.