Welcome to the Validation Processor
This application is currently still under development (Beta v0.1). Contact us on dwl8@leicester.ac.uk for feedback and more information on the application and all related queries.
The Validation Processor is intended for assay validation purposes only. Please do not upload sensitive information such as internal sample references or any patient identifiable data.
Introduction
The Validation Processor helps you turn raw bioanalytical and clinical assay data into a complete, accreditation-ready validation report — without spreadsheets or manual calculation.
Mass-spectrometry validation data exported from common software (e.g. TargetLynx ™ , LabSolutions ™ , Skyline ™ ) is imported, compiled and analysed experiment by experiment — calibration and model fit, limit of quantitation, bias and precision, carryover, dilution integrity, stability, matrix effects and interference.
You choose the validation guideline you are working to and the app applies that guideline’s acceptance criteria and expected experiments for you. Supported guidelines currently include ANSI/ASB 036 (forensic toxicology), ICH M10 , the FDA Bioanalytical Method Validation guidance, and CLSI C62 (clinical LC-MS/MS). Every limit and definition remains fully editable to match your own SOP.
When you are finished, a Word validation report is populated automatically with your results, pass/fail outcomes and the methods actually applied. For step-by-step help on any tab, open the Help menu (top right of the screen).
How it works
The validation workflow runs left to right. Each step is a tab in the sidebar; work through them in order.
Pick your validation guideline and confirm the acceptance limits and experiments.
Criteria & Definitions
Upload one file per batch. Sample types are auto-detected; adjust if needed.
File Importer
Set the calibration model for each compound (linear by default).
Model Selection
Check each experiment tab — QC, carryover, stability, matrix effects, interference.
Analysis tabs
Generate the populated Word validation report.
Validation Report
Tutorial
Using the application
Start in the Criteria & Definitions tab: choose your validation guideline and the app fills in that guideline’s acceptance limits and shows only the experiments it expects. Use the Experiments performed selector to auto-detect the experiments from your data, follow the guideline, or choose them manually. Every limit stays editable.
Next, open the File Importer tab and upload your validation data as separate batch files. The Validation Processor natively reads several common export formats. For other formats, select Other in the drop-down to open the File Formatter tab, where you can map the columns so the data is readable, then return to the File Importer to view the compiled data.
Once the data has been successfully imported, each validation batch file is processed and compiled into a single table within the File Importer Tab, where the filename of each batch is used as the 'Batch' column tag. This table is used for all other downstream processing. The software will automatically search for key terms in the 'Name' column in order to identify the Sample Type (e.g., 'Calibrator'). It is possible to define the Sample Type based on other naming conventions using the 'Edit sample types' option, either by using the drop-down selection table or by importing a 'Sample Type Key' .csv file.
Navigate through the tabs to explore and analyse the imported data. Of note, the Model Selection Tab allows the user to set the response function for each compound. By default, models are constrained to linear. The models selected here are used throughout the software to calculate concentration. Other user input variables are pulled through the application and are used for defining the Validation Report . This can be exported and reviewed for accreditation purposes.
Prerequisites for the data
Validation experiment raw data files must first be analysed in an appropriate processor (e.g., Skyline ™ ) to check the integrity of the data (e.g., chromatogram integration). Data should then be exported into files containing the following (or equivalent naming conventions):
- Compound name
- Sample name
- Concentration
- Peak area
- Internal standard peak area
- Response
These files can then be imported into the Validation Processor and analysed accordingly. For each batch, create a separate file with a unique name (e.g., Batch 1). Readable import files include: .csv, .txt, and .xlsx.
Below are some examples of validation data the user can upload into the Validation Processor for testing and exploring the application.
Please contact our team on dwl8@leicester.ac.uk about any questions and/or issues with this software.
Experimental design plan
Not sure how many samples, levels and batches you need? Download a design plan for your chosen guideline — an overview of every experiment with the recommended concentration levels, replicates, batches/runs and independent matrix sources, plus an approximate total sample count.
Select your guideline in the Criteria & Definitions tab first; the plan is generated for whichever guideline is currently selected. Values are a drafted starting point — always confirm against the guideline itself.
Download experimental design plan (.csv)