FAT/SAT, IQ/OQ packs, manuals and declarations of conformity, drafted from your engineering documents and checked against each customer’s requirements. Your engineers review and sign.
The engineering is reused. The documents are not. Each customer and site gets its own protocols, matrices and manuals, written by your best engineers.
The same machine answered from scratch against a new requirement document.
Last customer’s FAT, with last customer’s values still in it.
Schematics, calculations and test logs spread across teams and tools.
Punch lists and re-tests because a clause was missed months earlier.
Qualitum keeps the chain intact - as data, not documents.
What the engine reads, links and drafts. Every item keeps a link to the requirement it answers.
Coverage is measured against the clause, not against a template.
Engineering, maintenance and quality teams buying and accepting machines.
Project, engineering and documentation teams at OEMs. More for builders →
Same engine that runs pharma validation, applied to machine documentation.
Customer spec, your FS, schematics, calculations and past projects.
Each clause linked to the design evidence that answers it.
Protocols, matrices and manuals in the customer’s template.
Your engineers review and sign. Export in your own format.
We match each customer requirement to your functional specification and list what complies, what is partial and what is missing.
Our reference deployment is in pharmaceutical validation. Screens on this page show illustrative examples, not customer data.
Yes. Your templates, numbering and standard modules are the starting point for every draft.
Yes. Essential requirements of Regulation (EU) 2023/1230 are mapped to your risk assessment and technical file.
No. Agents draft and check. Your qualified people review, approve and sign every output.
In a single-tenant deployment inside your environment, with your choice of model, EU, US or UAE residency and air-gap capability. No training on your data.