Electronic 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.
Any combination of text, data, graphics, audio, or other information that is created, modified, maintained, archived, retrieved, or transmitted in digital form by a computer system, and which carries the same GxP obligations for accuracy, retention, and controlled access as its paper equivalent.
An electronic record is not simply a digital file — it is any digitally held information that serves the same evidentiary purpose a paper record would: a chromatography run, an electronic batch record entry, an emailed approval, a database entry that captures a GxP-relevant fact.
Because an electronic record can be trivially copied, altered, or deleted compared with paper, it depends on system-level controls — access management, audit trail, time synchronisation, backup — to preserve the same integrity a paper record gets more naturally from being a single physical object.
Where an electronic record is the official record of an activity, rather than a hybrid arrangement backed by a paper signature, the computerized system generating and holding it must itself be validated, and the record must remain retrievable in a readable form for its full retention period, including through any system migration.
- —Any GxP-relevant information created, held, or transmitted in digital form
- —Carries the same accuracy and retention obligations as an equivalent paper record
- —Depends on system controls — access, audit trail, time sync, backup — that paper does not need
- —Must remain retrievable and readable for its full retention period, including across migrations
21 CFR Part 11; EU GMP Annex 11; MHRA GXP Data Integrity Guidance (2018)
Frequently asked questions
What is Electronic Record?
Any combination of text, data, graphics, audio, or other information that is created, modified, maintained, archived, retrieved, or transmitted in digital form by a computer system, and which carries the same GxP obligations for accuracy, retention, and controlled access as its paper equivalent.
Which regulations cover Electronic Record?
21 CFR Part 11; EU GMP Annex 11; MHRA GXP Data Integrity Guidance (2018)