Herbal medicinal products
Plant material, herbal preparations and extracts.
- Examine each container: labels, damage, broken seals
- Start and run a process
- Assemble a batch dossier
Maluti QMS platform
GMP operations.
Connected.
Quality records, personal signatures and equipment data — in one system.
EquipmentReadings recordedLimits checked
ServerHosted by usor at your site
Personal keyPIN at every signatureKey stays on the card
- EquipmentReadings recorded, limits checked
- ServerHosted by us or at your site
- Personal keyPIN at every signature
Blockchain historyChanges remain traceable.HowClose
Records are written to a Hyperledger Fabric ledger that only appends. A correction is a new entry with who, when and why; the first version stays readable.
EU GMP Annex 11 §9
Personal signing keysSign with your own cryptographic key.HowClose
The private key stays on the person’s smart card; the PIN is asked at every signature. Each person signs only what their role allows, and the ledger checks it — not the screen.
EU GMP Annex 11 §14
Recorded telemetryCapture readings and verify their integrity.HowClose
Readings are stored in the site database and chained by hashes. The head of the chain is published to the ledger, so a reading changed afterwards no longer matches. One ledger transaction seals many readings — not every measurement is a transaction.
EU GMP Part I §3.19 · Annex 11 §7.1
GMP work, organised around your processes.
Documents & trainingKeep procedures, versions and training records together.
- Approve a new version and the previous one is withdrawn at the same moment.
- Issue numbered blank forms only for the version in force.
- See when each person’s training runs out; an expired training is flagged on the record.
Deviations & CAPARecord issues, actions and effectiveness checks.
- An instrument reading outside its limit opens a deviation automatically.
- Link corrective actions to the deviation and record whether they worked.
- Handle incidents, recalls, change control and self-inspection.
Production recordsConnect batch steps, signatures and supporting data.
- Configure process steps and the records required at each stage.
- Record each step with its signatures and instrument readings.
- Assemble the whole batch into one document for review.
Materials & suppliersLink incoming materials to supplier records.
- Record deliveries, specifications and certificates of analysis, and check one against the other.
- Keep each supplier’s licence and see when it expires.
- Score suppliers and assess risk (ICH Q9).
Equipment monitoringCollect readings and review excursions.
- Set limits for each measured parameter; readings outside them become deviations for review.
- Each figure shows which instrument it came from.
- Which instruments connect depends on their interfaces and is checked at your site.
- Temperature that follows the batch in transport partly built
People & accessAssign permissions to the people doing the work.
- Give each person a role; they sign only what the role allows.
- Administrators manage accounts but do not create quality records.
- Fitness-for-work status with dates — never a diagnosis — and room access that ends with it.
Industries
Start from what you make.
Explore the supported work and the limits for your production process.
Active substances
Chemical and natural active substances.
Scope and current limits →Non-sterile products
Tablets, capsules, liquids, creams and ointments.
Scope and current limits →Sterile products
Aseptic preparation and terminal sterilisation.
Scope and current limits →Medicinal gases
Gases and gas mixtures in cylinders and bulk.
Scope and current limits →Radiopharmaceuticals
Radioactive medicinal products.
Scope and current limits →Biological medicinal products
Products made by or from living organisms.
Scope and current limits →Advanced therapy medicinal products
Gene, cell and tissue therapies.
Scope and current limits →Wholesale distribution
Storage and transport under Good Distribution Practice.
Catalogue in preparation
Ask about your process →So far one direction — herbal — has had every step checked against the product’s code; its card lists tasks from that check. The others show their scope and limits on their own pages. Start from the operations on your GMP certificate →
See what stands behind a GMP record.
Review who signed, follow corrections and find the supporting information — without losing the original entry.
Example: a completed training record
Signed recordIllustrative record
Training completed
Anna Kowalska · SOP-014, revision 03
- Signed by
- Mark Nowak
- Role
- Qualified pharmacist
- Signed on
- 07 Sep 2026 · 09:43
- Applies to
- SOP-014, revision 03
- Valid until
- 06 Sep 2027
Signed with a personal key on a smart card. The key never leaves the card, so the server cannot sign in anybody’s name.
- 07 Sep 2026 · 09:43
- Recorded by Mark Nowak
- 07 Sep 2026 · 11:20
- Corrected by Mark Nowak
Completed on 17 Sep 2026 → 07 Sep 2026
Reason: the date was mistyped; the training took place on 07 Sep 2026.
The original entry stays readable next to the correction.
- Related requirement
- EU GMP Part I, ch. 2 §2.11 — training of personnel, and its effectiveness
- This record shows
- that the training on SOP-014, revision 03, was completed and until when it is valid
- It does not show
- whether the training was effective — that is assessed and recorded separately
The linked requirement provides context. This record shows the activity recorded in MALUTI.
Keep your equipment.
Connect your records.
We assess compatible instruments and configure MALUTI around your approved workflows.
Your equipmentMALUTIRecords & reports
Fully hosted, or your server + cloud (cloud reporting in development) · What works offline is agreed for your siteWhat to knowClose
- Fully hosted: we run MALUTI for you on servers in the EU; your team works in the browser.
- Your server + cloud: a server at your site keeps records and signatures; reports and access from outside go through the cloud.
- What keeps working without internet depends on the option and is agreed for your site.
- Cloud reporting for site servers is being built; ask us for its status.
- Each instrument is surveyed before we promise to connect it.
A clear starting point. A configuration that fits.
Core QMS
€2,600 / year
per site · excluding VAT · billed annually
Documents, training, deviations and CAPA.
Record history and access control included.
Extended production
€5,500 / year
per site · excluding VAT · billed annually
Core QMS plus production records, materials,
suppliers, monitoring and personnel.
Final pricing depends on selected modules and deployment. Implementation, hardware and technical support are quoted separately.Price list version 1, valid from 16 September 2026.Payment termsClose
- Invoiced annually in advance; payment within 30 days (Subscription Agreement 5.2, 5.4).
- A module or site added during the year is invoiced for the rest of that year only (5.2).
- 12-month term, renewing; you may end it at any time with 2 months’ notice (8.1, 8.2).
- No switching charges and no charge for exporting your data (5.6; Data Act Art. 29).
- No early termination penalty: months paid after the end are refunded pro rata (5.7).
- Reverse charge for customers in other EU countries; outside the EU the service is not subject to Polish VAT (5.3).
- Non-payment never stops recording, reading or exporting records (6.2).
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