Contemporaneous Recording
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 good documentation practice principle that a GxP activity be recorded at, or immediately after, the time it is actually performed — never reconstructed from memory hours or days later — so that the resulting record accurately and completely reflects what took place at the moment it occurred.
Contemporaneous is the “C” most often lost in practice: an operator who performs a step, delays entering it into the batch record until later in the shift, and then reconstructs the details from memory has broken contemporaneous recording even if every other field is filled in correctly.
The risk is not only honest forgetting — a delay between doing and recording creates an opportunity, deliberate or not, to adjust what gets written down to look more favourable than what actually happened, which is why contemporaneous recording is treated as a foundational control rather than a stylistic preference.
Practical support for contemporaneous recording includes designing forms and workflows so data can realistically be entered at the workstation where the activity happens, rather than requiring staff to carry information away and transcribe it later from a separate location.
- —Data must be recorded at, or immediately after, the time the activity occurs
- —Reconstructing an entry from memory later breaks this principle even if the content is accurate
- —A delay between action and recording is itself treated as a data integrity risk
- —Workflow and form design should make in-the-moment recording realistically achievable
FDA Data Integrity and Compliance With Drug CGMP Guidance for Industry (2018); MHRA GXP Data Integrity Guidance (2018)
Frequently asked questions
What is Contemporaneous Recording?
The good documentation practice principle that a GxP activity be recorded at, or immediately after, the time it is actually performed — never reconstructed from memory hours or days later — so that the resulting record accurately and completely reflects what took place at the moment it occurred.
Which regulations cover Contemporaneous Recording?
FDA Data Integrity and Compliance With Drug CGMP Guidance for Industry (2018); MHRA GXP Data Integrity Guidance (2018)