Glossary
Static Data / Static Record
A paper or electronic record format whose content is fixed, with little or no possibility for the user to interact with it.
Source · MHRA GxP Data Integrity Guidance (2018), §6.11.1 Original record
Details
A static record is useful for reading and retention but can lose the original dynamic functions such as reprocessing a chromatogram, expanding the baseline, or querying a trend. Inspections cite a dynamic original electronic record existing while only the printout or PDF was retained as raw data, narrowing what could be reviewed. Look at the original system files, the procedure for producing the printout, retention of metadata and audit trail, and the risk assessment for converting to static form.
Related sections
Related terms
Source
MHRA GxP Data Integrity Guidance (2018), §6.11.1 Original recordGRM Regulatory Glossary
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