Every customer sends a different URS, a different tender and a different template. Qualitum drafts the IQ/OQ, FAT/SAT protocols, compliance matrices and manuals from your own engineering data and their requirements, so every deliverable is pre-checked against what the buyer will audit.
The engineering is reused. The documents are not. Each customer, tender and site gets its own protocols, matrices and manuals, written by your best engineers instead of your newest ones.
The same machine, answered from scratch against a new 120-clause requirement document.
Last customer’s FAT, with last customer’s values still in it.
Drawings, material certificates, PLC exports and test logs are spread across teams and tools.
Punch lists, re-tests and delayed final payment, because a clause was missed in March.
In the customer’s template. Linked to the clause it answers. Reviewed and signed by your engineers.
Test steps, acceptance criteria and evidence fields, drafted from your FDS, drawings and the customer URS.
Every URS or tender clause answered comply, partial or deviate, with the evidence attached.
Operating and maintenance manuals kept consistent with the configuration actually delivered.
Declarations of conformity and technical files mapped to the regulation’s essential requirements.
Out: protocols, matrices and files, every clause traced, every gap flagged before it ships.
| Today | With Qualitum | |
|---|---|---|
| Who authors | Senior engineers rewrite protocols and matrices for each customer. | Agents draft from your data and the customer URS. Engineers review and sign. |
| URS coverage | Checked by reading. Clauses get missed. | Every clause matched to evidence or flagged as open. |
| Consistency | Values copied from the previous job. | Every value traced to the drawing or certificate it came from. |
| Customer FAT | Punch lists and re-tests for missed requirements. | Gaps closed in your office before the customer arrives. |
| Deployment | Shared drives and templates. | Single-tenant inside your environment. Your data stays yours. |
Send one customer URS and the documents you delivered against it. We return a gap report, then build your first package with your engineers.
The engine runs in production on the buyer side of pharma validation, reviewing exactly the supplier documents you produce. The matrix above is illustrative.
Yes. Upload the customer’s template and numbering scheme with the URS. Drafts come out in their format, so their QA reviews a familiar document.
No. Qualitum runs single-tenant inside your environment, with your choice of model. No training on your data, no retention outside your perimeter.
Your engineers and your authorised signatory. Agents draft and check. People approve and sign.
No. You deliver normal documents. If your customer also runs Qualitum, the trace links carry across, which shortens their review.