Original Record
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 first durable recording of an observation, result, or activity — whether on paper or electronic — as distinct from any later transcription, summary, or copy of it; the authenticity and completeness of a true copy is always judged against, and traceable back to, its original record.
Every GxP record has an original — the first form in which the data was actually captured. For a manual reading, that is the entry made directly into the logbook or form at the bench; for an instrument result, it is the electronic data file the instrument itself generates, not a later printout of it.
The concept matters most when a copy is in question: a certified true copy is only trustworthy because it can be shown to be a complete and accurate reproduction of a specific, identifiable original. Without a clearly identified original, there is nothing for the copy’s accuracy to be verified against.
Organisations should be able to state, for any given record, what its original is, where it is held, and how long it must be retained — a question that becomes surprisingly hard to answer when data has passed through several systems or transcription steps without that chain being documented.
- —The first durable capture of an activity or result, paper or electronic
- —A true copy’s accuracy is always verified against an identifiable original
- —For electronic data, the original is the underlying data file, not a printout
- —Every record should have a traceable answer to “what is the original, and where is it held?”
MHRA GXP Data Integrity Guidance (2018); FDA Data Integrity and Compliance With Drug CGMP Guidance for Industry (2018)
Frequently asked questions
What is Original Record?
The first durable recording of an observation, result, or activity — whether on paper or electronic — as distinct from any later transcription, summary, or copy of it; the authenticity and completeness of a true copy is always judged against, and traceable back to, its original record.
Which regulations cover Original Record?
MHRA GXP Data Integrity Guidance (2018); FDA Data Integrity and Compliance With Drug CGMP Guidance for Industry (2018)