Glossary
Raw Data
The original observations and the subsequent original records and data needed to reconstruct and evaluate an activity completely.
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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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 -
For example, investigators found numerous analysis reports, test methods, raw data…
FDA · FDA Warning Letter · 2024-06-18
