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Validation

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.

ValiTrac AI editorialUpdated 2026-09-132 min read

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. [1]EudraLex Volume 4, Annex 11: Computerised Systems
  2. [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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