Raw Data
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The original record — or a certified true copy of it — generated at the point an activity is performed, from which every reported or summarised result is ultimately derived; raw data must be preserved intact so the full activity can be reconstructed later, independent of any summary or conclusion drawn from it.
Raw data is the evidentiary foundation of a GxP record: the instrument printout, the balance reading, the chromatogram, the observation entered directly into a logbook at the time it occurred. A summary table, a certificate of analysis, or a validated report is built from raw data but is not itself raw data.
For electronic systems, raw data includes the underlying electronic file with its full metadata, not merely a printed or exported version of it — a PDF export of a chromatography run, for instance, is not a substitute for the original electronic data file and its audit trail.
Raw data must be retained for the full record-retention period applicable to that record type, in a form that allows the original activity to be reconstructed, checked, and, where necessary, defended during an investigation or inspection.
- —The original record from which every derived result or summary is built
- —For electronic data, includes the full underlying file and metadata, not just a printout or export
- —Must be preserved intact, unaltered, and retrievable for the applicable retention period
- —Distinct from a summary, report, or certificate of analysis built from it
FDA Data Integrity and Compliance With Drug CGMP Guidance for Industry (2018); 21 CFR 211.194(a); MHRA GXP Data Integrity Guidance (2018)
Frequently asked questions
What is Raw Data?
The original record — or a certified true copy of it — generated at the point an activity is performed, from which every reported or summarised result is ultimately derived; raw data must be preserved intact so the full activity can be reconstructed later, independent of any summary or conclusion drawn from it.
Which regulations cover Raw Data?
FDA Data Integrity and Compliance With Drug CGMP Guidance for Industry (2018); 21 CFR 211.194(a); MHRA GXP Data Integrity Guidance (2018)