Verify an analyzer in LabRuns and build its inspection binder.

Prepare an inspection binder with signed reports for precision, linearity, calibration verification, method comparison and reagent lots. Each report compares the results with your laboratory's limits. Explore this glucose binder for one chemistry analyzer to see the studies, imports and reviews used to prepare it.

The cover of the binder “Chemistry analyzer A · glucose”.
Page 2 of the binder “Chemistry analyzer A · glucose”: the contents, each study with its selected record, result and first page.
Page 3 of the binder “Chemistry analyzer A · glucose”: CAP evidence index page 1 of 3, each requirement with the report sections and pages that support it.
Page 4 of the binder “Chemistry analyzer A · glucose”: CAP evidence index page 2 of 3, each requirement with the report sections and pages that support it.
Page 5 of the binder “Chemistry analyzer A · glucose”: CAP evidence index page 3 of 3, each requirement with the report sections and pages that support it.
Page 6 of the binder: Glucose · calibration verification · Chemistry analyzer A, page 1 of 2: decision page, Met.
Page 7 of the binder: Glucose · calibration verification · Chemistry analyzer A, page 2 of 2: data listing and results.
Page 8 of the binder: Glucose · dilution verification · Chemistry analyzer A, page 1 of 2: decision page, Met.
Page 9 of the binder: Glucose · dilution verification · Chemistry analyzer A, page 2 of 2: data listing and results.
Page 10 of the binder: Glucose · linearity · Chemistry analyzer A, page 1 of 3: decision page, Met.
Page 11 of the binder: Glucose · linearity · Chemistry analyzer A, page 2 of 3: data listing and results.
Page 12 of the binder: Glucose · linearity · Chemistry analyzer A, page 3 of 3: results, continued.
Page 13 of the binder: Glucose · lot comparison · Chemistry analyzer A, page 1 of 5: decision page, Met.
Page 14 of the binder: Glucose · lot comparison · Chemistry analyzer A, page 2 of 5: data listing.
Page 15 of the binder: Glucose · lot comparison · Chemistry analyzer A, page 3 of 5: data listing, continued.
Page 16 of the binder: Glucose · lot comparison · Chemistry analyzer A, page 4 of 5: results.
Page 17 of the binder: Glucose · lot comparison · Chemistry analyzer A, page 5 of 5: results, continued.
Page 18 of the binder: Glucose · method comparison · Chemistry analyzer A, page 1 of 4: decision page, Met.
Page 19 of the binder: Glucose · method comparison · Chemistry analyzer A, page 2 of 4: data listing.
Page 20 of the binder: Glucose · method comparison · Chemistry analyzer A, page 3 of 4: results.
Page 21 of the binder: Glucose · method comparison · Chemistry analyzer A, page 4 of 4: results, continued.
Page 22 of the binder: Glucose · multi-day precision · Chemistry analyzer A, page 1 of 3: decision page, Met.
Page 23 of the binder: Glucose · multi-day precision · Chemistry analyzer A, page 2 of 3: data listing.
Page 24 of the binder: Glucose · multi-day precision · Chemistry analyzer A, page 3 of 3: results and study notes.
Page 25 of the binder: Glucose · repeatability · Chemistry analyzer A, page 1 of 3: decision page, Met.
Page 26 of the binder: Glucose · repeatability · Chemistry analyzer A, page 2 of 3: data listing.
Page 27 of the binder: Glucose · repeatability · Chemistry analyzer A, page 3 of 3: results.

Page 1 of 27Cover

Chemistry analyzer A · glucose

Grouped by analyzer · built Oct 23, 2026

  4. Chemistry analyzer A (CA-41027)

  5. Data 3 · report 1Calculated Oct 23, 2026, 13:25 UTC · signed off by Alex Rivera, MLS(ASCP)

    Pages 6–7Open this report (PDF)

  6. Data 4 · report 1Calculated Oct 23, 2026, 13:25 UTC · signed off by Alex Rivera, MLS(ASCP)

    Pages 8–9Open this report (PDF)

  7. Data 3 · report 1Calculated Oct 23, 2026, 13:25 UTC · signed off by Alex Rivera, MLS(ASCP)

    Pages 10–12Open this report (PDF)

  8. Data 3 · report 1Calculated Oct 23, 2026, 13:25 UTC · signed off by Alex Rivera, MLS(ASCP)

    Pages 13–17Open this report (PDF)

  9. Data 3 · report 1Calculated Oct 23, 2026, 13:25 UTC · signed off by Alex Rivera, MLS(ASCP)

    Pages 18–21Open this report (PDF)

  10. Data 2 · report 1Calculated Oct 23, 2026, 13:25 UTC · signed off by Alex Rivera, MLS(ASCP)

    Pages 22–24Open this report (PDF)

  11. Data 2 · report 1Calculated Oct 23, 2026, 13:24 UTC · signed off by Alex Rivera, MLS(ASCP)

    Pages 25–27Open this report (PDF)

CAP checklist edition 9 December 2025 · 9 requirements

COM.40300Unmodified FDA-cleared or approved nonwaived tests.

Laboratory recordsWritten assessment for each test and instrument, including investigation of discordant results.

  • Glucose · calibration verification · Chemistry analyzer A
  • Glucose · linearity · Chemistry analyzer A
  • Glucose · method comparison · Chemistry analyzer A
  • Glucose · multi-day precision · Chemistry analyzer A
  • Glucose · repeatability · Chemistry analyzer A
CHM.13550Chemistry AMR verification materials covering low, middle and high concentrations.

Laboratory recordsMaterial suitability and preparation instructions.

  • Glucose · calibration verification · Chemistry analyzer A
  • Glucose · linearity · Chemistry analyzer A
CHM.13600Chemistry AMR verification with applicable timing, triggers and exceptions.

Laboratory recordsAMR schedule and applicable event records.

  • Glucose · calibration verification · Chemistry analyzer A
  • Glucose · linearity · Chemistry analyzer A
COM.40475Approval of nonwaived test validation or verification before clinical use.

Laboratory recordsDirector or qualified designee signed written assessment and approval tied to each test and instrument.

  • Glucose · calibration verification · Chemistry analyzer A
  • Glucose · dilution verification · Chemistry analyzer A
  • Glucose · linearity · Chemistry analyzer A
  • Glucose · lot comparison · Chemistry analyzer A
  • Glucose · method comparison · Chemistry analyzer A
  • Glucose · multi-day precision · Chemistry analyzer A
  • Glucose · repeatability · Chemistry analyzer A
GEN.20377Laboratory record retention.

Laboratory recordsKeep method validation and verification records for the life of the test plus two years, or longer when applicable retention rules require it.

  • Glucose · calibration verification · Chemistry analyzer A
  • Glucose · dilution verification · Chemistry analyzer A
  • Glucose · linearity · Chemistry analyzer A
  • Glucose · lot comparison · Chemistry analyzer A
  • Glucose · method comparison · Chemistry analyzer A
  • Glucose · multi-day precision · Chemistry analyzer A
  • Glucose · repeatability · Chemistry analyzer A
GEN.20450Corrections to laboratory records.

Laboratory recordsRetained original values and traceable corrections.

  • Glucose · calibration verification · Chemistry analyzer A
  • Glucose · dilution verification · Chemistry analyzer A
  • Glucose · linearity · Chemistry analyzer A
  • Glucose · lot comparison · Chemistry analyzer A
  • Glucose · method comparison · Chemistry analyzer A
  • Glucose · multi-day precision · Chemistry analyzer A
  • Glucose · repeatability · Chemistry analyzer A
CHM.13710Chemistry results above or below the AMR.

Laboratory recordsReporting and dilution procedures.

  • Glucose · dilution verification · Chemistry analyzer A
CHM.13720Applicable chemistry dilution protocols.

Laboratory recordsValidated dilution protocol and diluent suitability.

  • Glucose · dilution verification · Chemistry analyzer A
COM.30450New reagent lots and shipments, including shipments of the same lot.

Laboratory recordsMaterial suitability and lot or shipment acceptance records.

  • Glucose · lot comparison · Chemistry analyzer A

example-binder-evidence.zip · 66 files · 13.1 MB · SHA-256 checksum for every file

  • binder.pdf4.5 MB
  • included-records.json18 KB
  • checksums.json10 KB
  • studies/001-Glucose - calibration verification - Chemistry analyzer A/9 files
    • calculation.json63 KB
    • revision.json8 KB
    • study-data.csv4 KB
    • results-summary.csv170 KB
    • imports/a5a9be64…/CHEM-A_LIN-2609_20260915.csv406 bytes
    • imports/a5a9be64…/mapping.json65 bytes
    • imports/a5a9be64…/settings.json432 bytes
    • report.html1.6 MB
    • report.pdf459 KB
  • studies/002-Glucose - dilution verification - Chemistry analyzer A/9 files
    • calculation.json39 KB
    • revision.json6 KB
    • study-data.csv3 KB
    • results-summary.csv51 KB
    • imports/ed5de511…/CHEM-A_glucose_dilutions_20260916.csv266 bytes
    • and 4 more
  • studies/003-Glucose - linearity - Chemistry analyzer A/9 files
  • studies/004-Glucose - lot comparison - Chemistry analyzer A/9 files
  • studies/005-Glucose - method comparison - Chemistry analyzer A/9 files
  • studies/006-Glucose - multi-day precision - Chemistry analyzer A/9 files
  • studies/007-Glucose - repeatability - Chemistry analyzer A/9 files

Keep precision, accuracy and linearity reports in one binder.

Choose the signed reports for an analyzer or an analyte, and LabRuns binds them into one PDF with a contents page and a CAP evidence index. You also get an archive of the data, calculations and imports behind every result.

Creating a report binder: the glucose studies for Chemistry analyzer A selected, each with its signed report version chosen.Creating a report binder: the glucose studies for Chemistry analyzer A selected, each with its signed report version chosen.
The binder’s contents before it is built: 7 glucose reports, each with its signed version and result.The binder’s contents before it is built: 7 glucose reports, each with its signed version and result.
The finished binder with Download PDF and Download evidence archive, and its contents listing each study with its result and first page.The finished binder with Download PDF and Download evidence archive, and its contents listing each study with its result and first page.

The binder includes each report as signed. A later correction produces a new report, and the binder retains the version you chose.

Start each study with a suggested collection plan.

Each Run this study guide explains what to prepare at the bench and how many specimens, runs or replicates the suggested design uses.

Set up of a glucose lot comparison with its suggested collection plan open and the study details filled in from the profileSet up of a glucose lot comparison with its suggested collection plan open and the study details filled in from the profile
Study details and acceptance limits of the lot comparison, with both lots and the specimen limit filled in from the glucose profileStudy details and acceptance limits of the lot comparison, with both lots and the specimen limit filled in from the glucose profile
The manual’s reagent lot comparison page, opening on Run this study with what to prepare and the suggested starting planThe manual’s reagent lot comparison page, opening on Run this study with what to prepare and the suggested starting plan

Open the Run this study guide for reagent lot comparison

Import your analyzer's results.

Save the column mapping for your analyzer's CSV or Excel export. Reuse it for later files to select the study columns and set aside test codes you chose to ignore.

CHEM-A_results_20261008.csv
Sample ID,Test,Result,Unit,Flag,Reagent Lot,Measured
LC-01,GLU,28,mg/dL,,GLU-R2609,2026-10-08 08:14:00
LC-01,HIL,H 6 I 1 L 9,,,GLU-R2609,2026-10-08 08:14:00
LC-02,GLU,45,mg/dL,,GLU-R2609,2026-10-08 08:16:17
LC-02,HIL,H 4 I 1 L 12,,,GLU-R2609,2026-10-08 08:16:17
LC-03,GLU,61,mg/dL,,GLU-R2609,2026-10-08 08:18:34
LC-03,HIL,H 11 I 2 L 8,,,GLU-R2609,2026-10-08 08:18:34
LC-04,GLU,72,mg/dL,,GLU-R2609,2026-10-08 08:20:51
LC-04,HIL,H 5 I 1 L 10,,,GLU-R2609,2026-10-08 08:20:51

and 55 more rows

Download CHEM-A_results_20261008.csv
Import review for the analyzer export, read with the saved format “Chemistry analyzer A results export”: the column mapping, the glucose results to import and the serum-index rows left outImport review for the analyzer export, read with the saved format “Chemistry analyzer A results export”: the column mapping, the glucose results to import and the serum-index rows left out
The Data grid after the import, with one result flagged for checkingThe Data grid after the import, with one result flagged for checking
A mistyped result corrected in the Data grid, its row marked CorrectedA mistyped result corrected in the Data grid, its row marked Corrected
A clotted specimen excluded from the statistics with the reason “Clot flagged by analyzer”A clotted specimen excluded from the statistics with the reason “Clot flagged by analyzer”

Set up each analyzer once in the Library.

Save the instrument, its analyte profiles, your reagent lots and the import format. LabRuns fills in these details when you start a study on that analyzer. When a new lot arrives, create its studies together from the profile.

Library, Analyzer profiles: Chemistry analyzer A with its Glucose profile, unit, allowable error and reportable rangeLibrary, Analyzer profiles: Chemistry analyzer A with its Glucose profile, unit, allowable error and reportable range
The Glucose analyte profile with its unit, method and allowable errorThe Glucose analyte profile with its unit, method and allowable error
Library, Materials and lots: the current and new glucose reagent lots, a chemistry control and the calibrator lotLibrary, Materials and lots: the current and new glucose reagent lots, a chemistry control and the calibrator lot
The saved import format “Chemistry analyzer A results export”, mapping each column of the analyzer export, with serum-index rows left outThe saved import format “Chemistry analyzer A results export”, mapping each column of the analyzer export, with serum-index rows left out
The studies a new reagent lot needs, reviewed before they are created from the analyzer profileThe studies a new reagent lot needs, reviewed before they are created from the analyzer profile

Work on the same study with colleagues.

LabRuns combines changes to different entries when you save. If you both change the same value, you choose which one to keep.

Priya NairEditor

The editor’s Set up of the lot comparison, with a new study date entered and not yet savedThe editor’s Set up of the lot comparison, with a new study date entered and not yet saved
The editor’s Set up after saving a new study titleThe editor’s Set up after saving a new study title

Alex RiveraOwner

The owner’s Set up of the same study, opened earlier, with the specimen matrix changedThe owner’s Set up of the same study, opened earlier, with the specimen matrix changed
The owner’s Set up after saving, with both changes in the study: the editor’s study date and the owner’s matrixThe owner’s Set up after saving, with both changes in the study: the editor’s study date and the owner’s matrix
Check the combined changes on the owner’s screen, naming the study title as the value both colleagues changed, with Review first and Save changesCheck the combined changes on the owner’s screen, naming the study title as the value both colleagues changed, with Review first and Save changes

You each edit your own draft. LabRuns shows the other person's changes when they save.

Change different entries and both changes are kept when you save.

If you both changed the same entry, compare the values and choose which one to keep.

Decide who edits and who reads.

Invite colleagues by email and give each one a role. Everyone signs in with their own account, so each sign-off carries the signer's name.

RoleWhat they can do
OwnerFull access, including inviting administrators, editors and viewers.
AdministratorEdits projects and studies, manages editors, viewers and project Trash.
EditorCreates and edits projects and studies, calculates results and signs off reports.
ViewerReads, downloads and signs off reports.
Settings, Members: a colleague invited as an Editor, with the next invitation being typedSettings, Members: a colleague invited as an Editor, with the next invitation being typed
A colleague’s first sign-in, with the workspace invitation and the Editor roleA colleague’s first sign-in, with the workspace invitation and the Editor role
Settings, Members: the owner, an editor and a viewer, with what each role can doSettings, Members: the owner, an editor and a viewer, with what each role can do

Review the results and sign the report.

Compare each result with your laboratory's limit, then sign the report under your own account when your procedure calls for it.

Fix a value after sign-off and recalculate. You get a new report to review, and the signed one stays on record.

Results show each criterion's limit, observed value and outcome. An Undecided outcome explains what is needed to evaluate the criterion.

Page 1 gives the decision, each limit beside its result and the sign-off at the foot of the page. The data start on page 2.

Open the report (PDF)

Once signed, the report and its PDF stay exactly as they are.

History keeps every report the study has had, newest first, with who signed each one and when.

A method comparison result corrected after sign-off, its row marked Corrected, with Recalculate results offered.A method comparison result corrected after sign-off, its row marked Corrected, with Recalculate results offered.
Results of the recalculated method comparison: Criteria met, each criterion beside its acceptance limit and outcome.Results of the recalculated method comparison: Criteria met, each criterion beside its acceptance limit and outcome.
The Report stage with the new calculation ready to sign, beside Download PDF, Print and the study’s history.The Report stage with the new calculation ready to sign, beside Download PDF, Print and the study’s history.
The Sign off dialog, which prints the signer’s account and date on page 1 and keeps the report and its PDF as signed.The Sign off dialog, which prints the signer’s account and date on page 1 and keeps the report and its PDF as signed.
History listing both signed reports of the study, newest first, with who signed each one and when.History listing both signed reports of the study, newest first, with who signed each one and when.

Plan recurring studies and new reagent lots.

Keep periodic checks and new reagent lots for each analyzer on one list, and start every repeat study from the last one you completed.

Recurring work for the glucose method on Chemistry analyzer A: new lot, shipment and planned studies by due date, above the two schedules.Recurring work for the glucose method on Chemistry analyzer A: new lot, shipment and planned studies by due date, above the two schedules.
A new reagent lot event, with the next lot chosen from the Library and Create next study.A new reagent lot event, with the next lot chosen from the Library and Create next study.
Set up of the next lot comparison, created from the event with the new lot and the last acceptance limit filled in.Set up of the next lot comparison, created from the event with the new lot and the last acceptance limit filled in.

Studies, statistics and workspace tools.

Compare each study's statistics and plots, and review imports, acceptance limits, reports, workspaces and hosting.

See every study, statistic and feature

Try the example, then verify your own analyzer.

Open the binder, its evidence archive and the live example without an account. Change the example readings to see how they affect the decision.

For your laboratory's software review, read the published methods and sources and the calculation checks. Run the studies in the evaluation package yourself, and review the institutional review information on data handling, access and support.

Start your free week Try a live example