Glossary
Raw Data
Also writtensource data
The original observations and the subsequent original records and data needed to reconstruct and evaluate an activity completely.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Raw Data Korean original
Details
Raw data covers not only the first observation but the metadata and subsequent processing records needed to reconstruct a GMP activity completely. Inspections cite the printout kept as the only official record, or deleted injections, reprocessing, and informal notes excluded, so that the original result and the decision cannot be reconstructed. Check together the electronic files of the method and the analytical system, audit trails, metadata, the calculation and reprocessing history, and the retention and review procedures.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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The final study report did not include descriptions of the following dosing issues, which were recorded on the raw data forms for Inhalation Exposure and PK Blood Collection: a.
FDA · FDA Warning Letter · 2026-10-13 -
For example, your (b)(4) Series HPLC instrument did not have sufficient controls to prevent deletion and alteration of raw data files…
FDA · FDA Warning Letter · 2022-08-30 -
Failure of the Quality Assurance unit (QAU) to review the final study report to assure that the reported results accurately reflect the raw data of the nonclinical laboratory study [21 CFR 58.35(b)(6)].
FDA · FDA Warning Letter · 2026-06-02
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
MFDS, 「알기 쉬운 GMP 용어집」, Raw Data Korean originalGRM Regulatory Glossary
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