Data integrity for temperature records: ALCOA+ in practice
Temperature records are GxP records. Attributable, legible, contemporaneous, original, accurate — plus complete, consistent, enduring and available — is the checklist.
Regulators expect temperature monitoring and mapping data to meet the same data-integrity principles as any other GxP record. PIC/S guidance summarises them as ALCOA+: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.
Applied to loggers and monitoring systems
- Attributable: which logger, which location, who downloaded it, who reviewed it.
- Original: the raw export retained unchanged; derived analyses stored separately with their inputs.
- Accurate: calibration status and uncertainty known; unit confirmed.
- Complete: gaps and exclusions visible, not silently dropped.
- Enduring and available: retained for the defined period in a readable format.
Software that computes statistics from logger data should preserve the input dataset, record the version of the calculation, and keep an audit trail of review actions — which is how ValiTrac's mapping engine is structured.
Frequently asked questions
- Is a screenshot of a logger graph an acceptable record?
- Not on its own. The underlying data export is the original record; a screenshot is a derived, non-verifiable representation.
References
- [1]PIC/S PI 041-1: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (2021)
- [2]EudraLex Volume 4, Annex 11: Computerised Systems
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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