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Use caseUC0098

Catch a batch's stability drift before the sample window shuts

Your stability studies get monthly reviews, but a result inside limits can still be drifting, and a missed sample date is gone for good. This app reads each review, calls the trend and flags any pull date about to be lost.

For the stability co-ordinatorChemicals · Pharma & Life Sciences

Why it matters

Today's manual process, and the same job with the app

A stability co-ordinator at a pharma or chemical plant, preparing the monthly trend review.

✕Today's manual process

1Open each study-condition and pull its trend chart from the stability database.
2Read the analyst's note to decide if a result is the product or the instrument.
3Walk the protocol calendar to find which samples must be staged before the next review.
4Miss a sample window and that timepoint is gone from the study for good.
Every study-condition checked manually, one by one.

✓With the app

1Every study-condition is read with its trend and its drift worked out.
2The note is checked against the result, and the call is written down.
3The pull calendar is read and any sample due before the next review is flagged.
4Nothing closes on its own the co-ordinator still opens the investigation.
Trend, drift and calendar checked every review.

See it work

One real case, read by the app, step by step

STB-0004-M6 comes in 2.51 points below where its trend expects it, and the lab note only describes a routine calibration.

Catch a batch's stability drift before the sample window shutsReference appBuilt to be shaped to your process
  1. 1The result month 4 reads 96.25%, still inside the registered limits.
  2. 2The trend the earlier months expect 98.76% here, give or take 1.20.
  3. 3The call out of trend: 2.51 below where its own trend expects it.
  4. 4Open the investigation the lab note shows only a routine calibration, so this is real drift.
  5. 5The pull calendar no sample missed; month 6 is due before its window closes on 21 July.

For engineers

How it is built, and how we measured it

All fourteen steps of the build are written up, from the business case to running it in your own environment.

Kit overview →
120 of 120correctly opened or heldmeasured in 06 Evals →
118 of 120reviews called in or out of trendmeasured in 06 Evals →
0 of 6investigations it missedmeasured in 06 Evals →
85¢to check all 120 reviewsmeasured in 07 Unit cost →

The build, step by step

14 steps

Make it yours

What you see is a reference app. We shape it to how you work.

Every part of it is built to change, and none of it means starting over.

Your rulesyour registered limits, method precision and trending rules.
Your recordsyour stability database export and lab notebook entries.
Your systemsconnected to your LIMS and quality management system.
Your screensthe study, batch and review fields your team already uses.

Want this for your team?

Talk to us

We can run this on your own stability programme, with your own limits and protocols, inside your environment.

Talk to us →
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