Dynamic vs Static Records
dynamic record · static record
A data-integrity distinction: dynamic records allow user interaction with underlying data (e.g., chromatograms); static records (e.g., PDFs) do not — both must be retained appropriately.
Regulators distinguish dynamic records — file formats that allow interactive review of the underlying data (e.g., re-integrating a chromatogram) — from static records (a printed or PDF rendering). For Part 11 / Annex 11 compliance, dynamic records must be retained in their original format with full metadata; reducing them to a static PDF for archival is a recurring inspection finding.
V5 keeps dynamic source files (chromatograms, instrument outputs) linked to their static signed renderings so both the original data and the certified view are available to an auditor.
- FDA Data Integrity Guidance (2018)
- MHRA GxP Data Integrity (2018)
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