Validating the software that analyses your monitoring and mapping data
Calculations that decide whether a space passed must themselves be verified — with known datasets, expected results and a record of the software version.
Whether the analysis runs in a spreadsheet, a monitoring platform or a dedicated engine, it produces GxP records and falls under Annex 11. Verification asks a simple question: given this dataset, does the software produce the right minimum, maximum, mean, hot spot, cold spot and excursion list?
A verification set
- A clean dataset with hand-verifiable statistics.
- Datasets with a single excursion of known duration and magnitude.
- Datasets with gaps, duplicated timestamps and a flat-lined sensor, to confirm they are detected and reported.
- A dataset in °F to confirm unit handling is explicit, not inferred.
- Datasets at the acceptance limit to confirm boundary behaviour.
Deterministic engines make this straightforward: the same input yields the same output, so a verification set can be re-run automatically after every change. ValiTrac's engine ships with such tests and records the code version alongside every result.
Frequently asked questions
- Do spreadsheets need validation?
- Yes, if they produce GxP decisions. Locked templates, version control and verification against known data are the usual controls.
References
- [1]EudraLex Volume 4, Annex 11: Computerised Systems
- [2]EudraLex Volume 4, Annex 15: Qualification and Validation (2015)
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
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