Voice Recordings during GLP-driven Necropsy

Pathologists in preclinical R&D are often called during GLP-necropsies to assist or to advice on terminologies. Occasionally, in smaller laboratory settings, pathologists may perform the full necropsy themselves and record the findings by written means with audit trail compliance tools

But why Pathologists are not recording their gross findings through voice recordings and use these for report writings instead of written documentations? Could the potential recordings be used as a supplement and if yes, how would this be audited or archived?

First of all, the pathology report contains macroscopic findings, which should be correlated with the microscopic findings. Therefore, it remains important for the pathologist to have access to the gross changes when reading the slides. According the GLP practices, pathology notes are not considered raw data. It is the signed pathology report which represents the raw data along with the slides, because another pathologist will be able to reconstruct the study. However, GLP guidelines state clearly that those necropsy dictations must be transcribed verbatim and should be verified as exact transcriptions. Gross pathology findings or macroscopic observation data collection are still considered to be crucial to the ‘reconstruction’ of the pathology report. The question should remain if you can work backwards from the pathology report and find the first recording of the gross observations. All raw data must comply with 21 CFR Part 11; 58.130(e) and 58.3(k).

Having said this, no matter who collects gross observations during necropsy, no matter how they were collected, the initial entry of it remains the raw data. So, if the observations at necropsy are recorded by voice recording then they must be transcribed to some type of written media by a GLP-trained person, who then checks their work and then a second person should listen to it and confirms that the entries are correct. It is this copy of the initial entry (raw data) that can be used by the pathologist and they should be included in the pathology study report. Therefore, it seems logic that the voice recording should be maintained as necropsy raw data. Voice recordings degrade over time and although 58.3(k) permits substituting an exact transcript for the original source, it still remains good practice to save and archive the voice recordings. The full process should be defined by company SOP’s.