Reuse
Past projects become answers.
Standard modules and variants are matched to each new URS line.
Qualitum turns your customer’s URS into a compliance matrix, FS/DS, FAT/SAT and IQ/OQ protocols, built from your own templates and past projects. Your engineers review and sign. Your customer’s QA gets a package it can approve first time.
Different machines, the same problem: a validation package per project, against a different customer URS every time.
Customer URS response, FS/DS, serialization and vision FAT, IQ/OQ, Part 11 evidence.
P&ID-based FS, HDS/SDS, material and weld certificates, FAT/SAT and IQ/OQ.
WFI, PW, Pure Steam and HVAC: design qualification, IQ/OQ, ISO 14644 classification records.
GAMP 5 Cat. 4/5 software: FS, configuration and design specs, test scripts, traceability.
The machine is engineered once. The paperwork is rewritten for every customer, by the engineers you most need on the next project.
Someone re-reads 300 requirements and fills a compliance matrix by hand.
It is written from last project’s FS, not from this customer’s URS.
FAT and IQ/OQ are reused, and the customer’s QA finds the gaps at FAT.
Document rounds delay FAT, SAT and your milestone payment.
From a supplier we spoke toA European pharma packaging-line builder was spending an estimated ~500 engineering hours a month on URS responses, functional specs and IQ/OQ documentation.
Your engineers stop retyping and start reviewing. Every section knows which URS line it answers.
PDF, Word or Excel. Agents decompose it into testable, risk-tagged requirements.
Comply, partial or deviation, with a comment, against your standard machine capabilities.
FS/DS and FAT/SAT/IQ/OQ from your templates, every section traced to a URS line.
Your engineers review and sign. Export Word, Excel or PDF in your own format and numbering.
We will publish supplier numbers once our first supplier pilots are measured. Until then, no invented figures.
Your past projects, standard FS modules and machine variants become a reusable knowledge base. Every new URS is answered from what you have already engineered and documented.
Standard modules and variants are matched to each new URS line.
The library and every generated document belong to you.
Single-tenant in your environment, or hosted for you in the EU.
Your documents never improve anyone else’s model.
Your customer’s QA has to approve every document you send. A package where every section traces to their URS means fewer FAT findings, fewer review rounds and faster SAT sign-off.
Every requirement classified comply / partial / deviation, with a draft comment, plus a list of requirements your FS doesn’t yet cover if you attach it.
Annual subscription sized to your project volume, cancellable quarterly. Start with a limited pilot on one machine line.
No. You deliver normal Word, Excel and PDF documents in your own format. If your customer also runs Qualitum, the trace links carry across and shorten their review.
Yes. Your document templates, numbering scheme, terminology and standard FS modules are the starting point for every draft.
Yes. It reads customer URS documents in German and other major European languages and drafts responses in the language of the URS or in your working language.
You do. Everything drafted, and the library built from your past projects, is your intellectual property.
In a private single-tenant deployment in your environment, or hosted for you in the EU. No training on your data.
No. Agents draft. Your engineers review, approve and sign every document.
A pilot runs on one machine line, on a real customer project, with scope and duration agreed up front.
Yes. Many suppliers start there and add FS/DS and protocol authoring later.
Two ways in. Pick whichever fits the week you’re having.