Assemble an evidence binder

A binder puts the study reports you choose into one document, grouped by analyte or analyzer, with a contents page and a CAP evidence index. Each study keeps its own result.

Open Reports from the sidebar, then Binders and choose Create binder. Filter by project, analyte, analyzer, study type or study date. Select the studies and their report versions, give the binder a name, and choose whether to group by Analyte or Analyzer.

A current saved calculation is selected when available. If a study has changed, choose a preserved report explicitly or calculate the current data before including it. Review the selected data and report versions under Review contents, then choose Build binder.

A panel comparison also offers Create binder with its comparisons selected. Its binder includes a summary of the primary regressions, decision-level biases, labeled predictions and specimen acceptance.

The finished binder lists each study, its result and the page where its report starts. Every page after the cover carries its binder page number at the top right, the number the contents and the CAP evidence index cite. Its cover names the laboratory and gives the creation date and time in UTC. Download PDF gives the whole binder as one document. Download evidence archive gives a ZIP with that PDF, each study's own report, its saved calculation as JSON, its results as CSV files and the original import files, together with a manifest of the versions included and a checksum for every file.

The binder keeps the included reports' text, headings, table structure and reading order for assistive software. Its bookmarks open the contents and each selected report.

The CAP index names the checklist edition and, study by study, each requirement that applies, the report sections and pages that support it and the laboratory records that go with it. Requirements for one discipline or test category, such as the chemistry AMR requirements or COM.40300 for an unmodified FDA-cleared test, are listed for studies you created from an analyzer profile, which records the test's discipline and category. AMR requirements are listed for a linearity or calibration verification study that checked a claimed reportable range, and their Range coverage page is the one with that range's table.

Select Include a paper assessment and approval page when the laboratory wants a printed record of its assessment. The page identifies the included test, instrument and data versions and provides lines for the laboratory's decision and reviewer signature. The optional director line follows the project's own setting.

Keep verification and validation evidence for the life of the test plus two years, or longer when applicable retention rules require it. A saved binder keeps its selected reports and files together; create another binder to include later work.