Research and development only — not a validated LIMS, GMP batch disposition, or 21 CFR Part 11 system. Supports vendor-produced text result exports (.csv, .tsv, .txt), not proprietary raw binaries (.raw, .eds, .fcs, .xad, electropherogram projects), chromatographic integration, or qPCR curve fitting. Source files are not uploaded, saved automatically, or embedded in project reports. Preserve originals and SOP-controlled acceptance criteria in a secure system. Do not import patient-identifiable or confidential data.
1 · Import results export2 · Verify column mapping3 · Review QC criteria4 · Download evidence report
1 · Instrument export
Maximum 5 MB. Choose a result/peak/region table exported by your instrument software. For Excel .xlsx/.xls, use the instrument software to export a CSV before importing.
2 · Verify imported columns
Confirm that headers correspond to the instrument's exported result table. If the wrong row was detected, export a clean flat results table instead of changing the header manually.
No file loaded.
3 · Assay qualification worksheet
Enter only limits that have been prospectively specified in a controlled method or study plan. Missing criteria remain “Not assessed.”
Validation gate: Precision, bias/recovery, specificity, linearity, reportable range, robustness, sample stability and interference must be qualified for the intended analytical purpose. This worksheet checks only the numerical limits provided here; a clean report is not proof of analytical method validation.
Method qualification evidence register
References below record where supporting validation evidence may be found; entering them does not mean the assay is qualified.
Coverage by assay family
- qPCR: Cq/Ct table import; amplification/melt curves and ΔΔCq not reconstructed from an export.
- ddPCR: imported copies/µL or concentration; event-to-copy calculation requires separate validated droplet volume/threshold inputs.
- LC–MS: peak areas/abundances; no cap percentage without peak identity, response calibration and a suitable quantitative method.
- Bioanalyzer: peak and region statistics; does not parse electropherogram binaries or infer RNA integrity from arbitrary areas.
- Plate readers: RFU/RLU/OD exports; blank and calibration controls must be independently verified.
Official documentation and guidance
4 · Review results and generate a research report
—Imported rows
—Sample/analyte groups
—Groups with excursions or missing measurements
—Source SHA-256 prefix
Import an instrument results table to populate the summary.
| Sample ID | Analyte | n quantified / total | Mean | SD | %CV | Recovery % | Review status |
|---|---|---|---|---|---|---|---|
| No imported measurements. | |||||||