Glossary
Original Data / Original Record
The record in which information was first captured, or a verified true copy that preserves its content and meaning.
Source · PIC/S PI 041-1 (2021), §§7.4, 13; MHRA GxP Data Integrity Guidance §6.2
Details
Originality preserves the first captured data with its context and metadata, and so prevents selective transcription or reconstruction. Inspections cite retention of a calculated summary or printout instead of the original electronic file, and discarded temporary records. Look at the basis on which raw data is designated, the files stored on the instrument, metadata and audit trails, and how true copies are created, certified, and retained.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your laboratory records lacked complete and original data to support the analyses performed.
FDA · FDA Warning Letter · 2026-01-27 -
Your laboratory records lacked complete and reliable original data to support the chromatographic analyses performed on over-the-counter (OTC) drug products and components.
FDA · FDA Warning Letter · 2025-03-18 -
For example: Our investigators observed original data (e.g., pH test records) discarded in the trash located in your in-process laboratory.
FDA · FDA Warning Letter · 2024-12-03
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PI 041-1 (2021), §§7.4, 13; MHRA GxP Data Integrity Guidance §6.2GRM Regulatory Glossary
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