Maluti QMS

Detailed catalogue — every operation, record type and module in full. Back to the main site · Industries · Pricing

Quality records for a regulated site

Every record.
A named person.
A traceable history.

A quality management system connecting your work to the record, the signature and the clause behind it.

Find your site Explore the catalogue

See what the product records today — and what it does not.

MALUTI / RECORD DETAIL Illustrative record

Signed record

Training completed

SOP-014 · Production documentation

Source snapshot

01 / At your site

Your site. Your records. Personal signatures.

With a server at your site, records are made, signed and kept there, and the work does not stop when the internet does. MALUTI can also be fully hosted by us; what works without internet is then agreed for your site.

  1. Workstations and tablets Where people record their work and sign it with their own card.
  2. Your site server The application, its database and your site's own Hyperledger Fabric network. Every record is kept here.
  3. Shared anchor channel Receives a confirmation for each released batch, when the link is up.
  • With a server at your site, records stay there. The database and the ledger that holds them are on your server.
  • With a server at your site, recording goes on without the internet. Recording, signing, correcting and reading records do not wait for the link. Only the batch confirmations wait: they are queued in the site database and sent when the anchor answers.
  • Every signature is a personal key. The private key stays on the person's card, and the PIN is asked at every signature (Annex 11 §12.1).
What leaves your site

To the shared anchor channel, and only this: for each released batch, its batch number, the name of the release file and the SHA-256 hash of that file. The release document itself stays at the site, and so does every other record.

Readings from instruments stay at the site too. What is committed for them is the head of their hash chain, and it goes to your site's own ledger.

What the ledger is not. No coin, no mining, no public chain: every writer is a named identity holding a certificate. And it does not make wrong data right: the ledger proves what was signed and when, not that the measurement behind it was true.

02 / Find your site

From your product to its records.

Choose what your product is used as, then the operations printed on your GMP certificate. The page names the documents that govern you, what each wants a record of, and which of those this product keeps today.

1 Intended use 2 Operations 3 Records and gaps 4 Price

Select an operation to continue

See the records clause by clause

03 / The catalogue

A place for every kind of work.

Ten areas, counted from the catalogue and not written by hand. Press one to see its sections. Figures count the records MALUTI keeps, not how ready your site is.

About these figures

For each area of work: how many records the rules ask for, and how many of them this product actually keeps. Where the number is low, it is printed low.

How to read the figures. A work is one thing a site does that some clause demands a record of, and each one in our catalogue carries its document and paragraph. Built means the product keeps that record today. The rest are named, routed and waiting, not hidden.

04 / People and responsibility

Whoever you are, this part is the same.

Chapter 2 of Part I asks the same of an oxygen plant and of a herbal extraction: who is responsible, what they may decide and what they were trained on.

05 / Manufacturing directions

Coverage, with its boundaries visible.

Choose a direction: its governing document, how many of the records it asks for MALUTI keeps, and whether its process is written out step by step.

Compare all directions
DirectionGoverning document WorksBuiltNot read by us Process

06 / The product

Eleven modules. One record system.

What the product is made of. The state beside each module is read off the build, not written here.

07 / Why this differs

How the record earns your trust.

Three things, each in one sentence. Open one and it says how it works and what state that part of the build is in.

A history you can check

Every entry goes to an append-only ledger where each block carries the hash of the one before it, so a record altered afterwards stops matching and says so.

How it works

Annex 11 §9 asks for an audit trail. In most systems that trail sits in the same database as the record, under the same administrator, who can reach both. Here the administrator of the site cannot rewrite history without every peer disagreeing.

built — chaincode 48.0, on a live network

The maker does not certify

Whoever did the work cannot be the one who certifies it.

How it works

The separation lives in the record itself, not in a procedure somebody has to remember at the right moment.

built

We publish what we miss

The pre-inspection report carries a third kind of line beside the two everyone prints: not recorded here.

How it works

A system that can only say yes or no about itself is telling you half of what you need before an inspection.

built inside the product, not published on this page yet

09 / Documents

Documents for evaluation and launch.

How the system is built, how data are handled, and what applies before a contract. Ask us for anything else your evaluation needs.

10 / Prices

What MALUTI costs.

The price is made of the modules you choose and the conditions of launch at your site. The software is a yearly subscription. Hardware and launch are worked out once for the agreed configuration; technical support is chosen separately. No registration is needed to read it.

Start with the work you need to record.

Find your scope, read the catalogue and see the gaps named.

Find your site