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Use caseUC0127

Catch a batch's certificate lines that can't be signed

A certificate of analysis is a promise the customer relies on, not just a summary of lab numbers. This app checks every required result against the specification and refuses any line it can't support.

For the quality assurance deskChemicals · Pharma & Life Sciences · Manufacturing & CPG

Why it matters

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

Quality assurance staff at a chemicals or pharmaceutical plant, drafting the certificate before a batch ships.

✕Today's manual process

1Read the whole result pack against the customer's specification before drafting anything.
2Check every method and instrument one determination at a time, cross-checking calibration dates.
3Search the lab notes for anything that quietly invalidates a result that looks fine.
4One missed note and a certificate ships with a claim nobody can support.
Every batch checked manually, line by line

✓With the app

1The pack is read in full every determination checked against the specification now in force.
2Method, instrument and standard are checked for each result, not just the number.
3Every note is read too so a quiet invalidation can't slip through.
4Each line gets a clear answer certify, or refuse and say exactly why.
The app checks every line first

See it work

One certificate, recorded: what each line was refused for

Batch CD-0002's chloride and toluene tested fine, but both used a reference standard the supplier had withdrawn.

Catch a batch's certificate lines that can't be signedReference appBuilt to be shaped to your process
  1. 1The reported result 16.5 ppm chloride, checked against the limit now in force.
  2. 2Refused anyway the reference standard behind this result had been withdrawn.
  3. 3A method problem too the assay ran on a method the specification doesn't allow.
  4. 4A late invalidation the lab voided this sequence after the fact, so it can't count.
  5. 5Held, not signed four of six lines are refused; the certificate can't be issued as drafted.

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 →
96 of 96unsupportable results caught before signingmeasured in 06 Evals →
332 of 333certificate lines matched exactlymeasured in 06 Evals →
1 of 237conforming lines held back by mistakemeasured in 06 Evals →
1.6¢to draft one certificatemeasured 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 own specifications, revisions and limits, exactly as your quality system keeps them.
Your recordsYour lab results, instrument logs and reference-standard records, in the formats you already keep.
Your systemsReads from your lab system or document store; drafts go to whoever signs them.
Your screensThe certificate layout, fields and wording your quality team already uses.

Want this for your team?

Talk to us

We can run this on your own specifications and lab results, inside your environment.

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