Qualify the method.
Keep the evidence attached.
A qualification is a plan, a set of plates, and a judgment about whether the method did what the plan asked. Today those three live apart: the plan is a document, the readings are exports, and the report is typed from both. The platform keeps them as one object, so the report is the study rather than a description of it.
The unit of work
A study plan, its plates and its verdicts held as one object
The judgment
Acceptance criteria machine-evaluated, or adjudicated by a named reviewer
The output
A qualification report drafted from the study, every figure bound to source
A qualification, assembling itself
Plates are taken up, the curve is fitted from the readings, and each characteristic is judged against the plan it came from.
evaluating against the planPlate layout · 96 well
Standard curve Signal (OD)
4PL model
y=d+a − d1 + (x/c)bThe cost you are already paying.
The plan and the report are two documents that have to agree
Criteria are written once in the study plan and typed again into the report, months later, by someone reconciling them against a spreadsheet of readings. Where they disagree, nobody finds out until review.
Out of trend is nobody's job
Out of specification is a bright line and gets caught. Out of trend needs the method's own control history beside the result, and that history sits in files that are not opened between qualifications.
A borderline call is invisible afterwards
Somebody decided a result was acceptable. Six months later the reasoning is gone, the reviewer has moved on, and the only record is a number that passed.
On the platform.
Criteria are evaluated where they were written
The acceptance criteria in the study plan are the ones applied to the readings. Where a criterion cannot be evaluated it says so, and a named reviewer adjudicates it on the record rather than quietly.
The method carries its own history
Every qualification adds to the control history for that method, so the next result is read against what the method has actually done, not only against a limit.
Readings arrive as records, not exports
Plate readings are attached to the study that asked for them, so a qualification is assembled from data already in place rather than from files emailed around after the run.
The report is the study
The qualification report is drafted from the plates and the verdicts it describes. Change a reading and re-generate, and the document changes with it.
Related capabilities
Bring us the work you already know the answer to.
We would rather you judge the platform against a result you can already check than sit through a scripted tour.
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