What is required to produce GLP-compliant raw data when recording observations with a voice recorder?

• A. The recording must be transcribed and verified by the person who made the recording, with signature (or initials), date, and statement of accuracy
• B. It can be used without transcription
• C. It must be converted to a spreadsheet by someone else
• D. It should be annotated by a supervisor only

Answer: (A)

Under GLP, raw data must be complete, accurate, and attributable to the person who generated them, with a clear and auditable trail. When observations are recorded by voice, the content is not immediately usable as a readable record. Transcribing the recording into text makes the observations readable and reviewable, which is essential for data integrity and oversight.

But transcription alone isn’t enough. It must be verified by the person who made the recording to confirm that the written text faithfully reflects exactly what was spoken, preventing transcription errors and ensuring the transcription captures the intended observations and context. Adding a signature or initials identifies who performed the transcription and when, anchoring accountability. Including the date and a statement of accuracy further documents that the data are complete and correct and that the recorder stands behind the transcription. Together, these elements create a traceable, defendable record suitable for GLP audits.

The other approaches don’t provide the full required trail. Using the audio without transcription leaves the data unreadable and without a formal record of accuracy or who produced it. Having it converted to a spreadsheet by someone else can alter the form and potentially the content, and it typically lacks the necessary verification, attribution, and accuracy statement from the original recorder. Annotation by a supervisor alone also does not establish the original transcription, attribution, or a verified accuracy statement.