QualRun — an instrument
The evidence, assembled.
Import · prove · release. QualRun reads your validation and capability data, does the statistics honestly, and assembles the evidence package a review actually needs — so the work of proving a process is not rebuilding a spreadsheet from scratch every time.
The problem it goes after
The analysis is not the hard part
A process engineer running a validation usually knows exactly which statistics are needed. What eats the week is getting the data into shape, running the same calculations again in a spreadsheet somebody built in 2019, and assembling the output into a document a reviewer will accept.
QualRun does the assembling. The judgement stays yours.
Where the boundary is
What QualRun deliberately is not
Your QMS stays the system of record. QualRun is an analysis and evidence tool that sits beside it, not a replacement for it. It does not store your master records and it does not become the thing an auditor points at.
No electronic signatures. No Part 11 claim. We are not telling you this software is validated for that purpose, because it is not, and a vendor who implies otherwise is handing you a problem you will discover at the worst possible moment.
It does not sign anything off. A quality manager reaches a conclusion and puts their name to it. QualRun gets the evidence in front of them faster; it does not have an opinion they are obliged to accept.
The part most vendors skip
What has actually been tested
QualRun is a finished piece of R&D, not a shipped product. It has been validated on synthetic data and has no design partner yet.
Everything it does, it does correctly on data we generated with the right answer known in advance. Nobody has yet run their own validation through it.
What a design partner gets
- Direct say over what it does next. A prototype with one real user is shaped by that user. That is the whole point of the arrangement.
- Your real validation data, run alongside your existing method — not instead of it. You keep doing it the way you do it, and compare.
- An honest answer when it is wrong. Where our statistics disagree with your established method, we work out which of us is right rather than defending the software.
- No production or release decision depends on it while it is a prototype.
Who it is not for, yet
If you need validated software with electronic signatures for a regulated release process today, QualRun is not that and will not be for some time. Worth saying now rather than three meetings in.
Want a say in what it becomes?
Tell us what your validations look like now and where the week actually goes.