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Product

Eleven modules. One record.

Every module writes to the same signed, append-only record. Three come with every site; the others you choose. Open a module to see what it records and what is not built yet.

Included with every site

The record itself: history, access and resilience come with the site fee.

Record historyAvailable Every entry anywhere in the product is appended, attributed and never overwritten. Included with every site
  • Every entry is appended; nothing is ever overwritten.
  • A correction is a new entry that supersedes the old one and states its reason.
  • Every action is tied to the person who signed it, not to a name somebody typed.
  • Every line of a batch dossier names the ledger transaction behind it.
System resilienceAvailable Keep recording when the link goes down — with a server at your site — and prove that a backup restores. Included with every site
  • With a server at your site, recording goes on when the internet link is cut.
  • What has to leave the site waits in a queue and is sent when the link returns.
  • Backups are restored to check them, not only copied.
  • The site issues its own signing certificates.
Access controlAvailable Decide who may do what, with the record itself checking it rather than a menu. Included with every site
  • Sign in with a smart card; the key never leaves it.
  • An administrator cannot write a record at all.
  • The role comes from the person's certificate, and the ledger checks it, not a menu.
  • A revoked certificate is turned away by the ledger peer itself.

Quality system

Documents, training, deviations and corrective actions.

Documents and trainingAvailable Know which version of a procedure is in force, and who is trained on it until when. €800 per site per year
  • Approving a new version of a procedure supersedes the previous one in the same step.
  • A numbered blank form cannot be issued against a version that is not in force.
  • Training carries the date it runs out; when it lapses the record is flagged and work is not refused.
Deviations and corrective actionsAvailable Handle what went wrong: deviations, corrective actions, incidents, recalls and changes. €600 per site per year
  • A deviation is raised by the record itself when an instrument leaves its limit.
  • Handle incidents that reach beyond one batch, and recalls.
  • Run change control and self-inspection.

Production

Materials, suppliers, batch records, instruments and people.

Raw materialsAvailable Follow material from planting and delivery to a batch ready for release. €600 per site per year
  • Number every plant at planting and keep its field records.
  • Weigh the harvest wet and dry, component by component.
  • Receive a delivery the grower declared and somebody else weighed.
  • Judge a certificate of analysis against its specification in the record, not by eye.

Built around plant material: plantings, harvests and deliveries from growers.

Suppliers, contracts and riskAvailable Know whether a supplier's licence is valid before its certificate of analysis is relied on. €600 per site per year
  • Keep each counterparty's licence and the day it expires in the record.
  • Whether a licence is still valid is checked at the moment it is relied on.
  • Score suppliers in numbers.
  • Assess risk on the ICH Q9 matrix, where severity 5 is critical on its own.
Telemetry and electronic batch recordsAvailable Record a batch as it runs: its process steps, its holds and the readings of instruments. €900 per site per year
  • A breach of storage conditions raises a deviation on its own.
  • Configure process steps and run batches against them.
  • Assemble the whole batch into one dossier, sealed so that a later change shows.
  • Readings go to the site database; only a summary hash goes to the ledger.
Personnel, fitness for work and room accessAvailable Keep each person's file, their fitness for work and their permits to enter rooms. €800 per site per year
  • Keep each person's file and the checks the law asks for.
  • Record fitness for work as one of three words with its dates, never a diagnosis.
  • A room permit never outlives what it rests on.

Specialised

Reporting and distribution, where your market needs them.

Reporting to the authoritiesAvailable Report to the state from what is already recorded: quota, export permits, waste and the annual return. Priced for your site
  • Count quota in active substance, not in weight.
  • Check an export permit against regulation 24, the importing country's certificate first.
  • Record waste as an object of its own: weighed, denatured and destroyed in that order.
  • Assemble the annual return from what is already recorded.

Built for the Lesotho regulations (LN40) today; other national reporting is prepared on request.

Transport, cold chain and packagingPartly built Move product with its custody and temperature, and pack it with its labels reconciled. Not offered yet
  • Transfer custody by name, vehicle and receiver.
  • Declare the storage condition on the batch and judge every leg against it.
  • Pack with materials, line inspection, label reconciliation, seals and serial numbers.

Not built yet:

  • Uploading the unique identifier to the European hub
  • Controlling the label printer itself, so that every imprint conforms to the print specified in the batch record

How the record holds up.

What stands behind every module.

  • Append-only history. A correction is a new entry with who, when and why; the original stays readable. EU GMP Annex 11 §9
  • Personal signing keys. The key stays on the person’s smart card; the PIN is asked at every signature. Annex 11 §14
  • Checked by the ledger. Each person signs only what their role allows, and the ledger checks it — not the screen.
  • Sealed readings. Instrument readings are stored at the site and their chain is sealed in the ledger, so a later change shows. Annex 11 §7.1

Let’s map MALUTI to your site.

Tell us about one of your processes. We show the matching functions, name the integrations it needs and prepare an individual offer. Documents for supplier evaluation →

Discuss your configuration