FDA considers the original data the be the record(s) you generate during the execution of the protocol. If you’re handwriting data as you execute the steps of the protocol, then the handwritten record would considered the original and you must maintain it as such. If you want to transcribe the handwritten data, you could create a validated/qualified transcription process, however, you would still maintain the handwritten original. Additionally, the electronic transcriptions must also be maintained as auditable electronic records (since you’re likely using the transcription to make pass/fail decisions) so there would be absolutely no business advantage since you’re essentially doubling the work of record maintenance. Regarding this statement,”These could not be technically considered ‘electronically’ completed as the software storing the documents does not have electronic signature capability,” this is a common misconception that I’ve seen before. An electronic record isn’t defined by having an electronic signature, it’s defined by the source/use of the data (ie to make GxP decisions). An electronic record can be approved as easily by a handwritten signature as an electronic signature, however, the electronic record must still have appropriate access controls and audit trail.
Overall, it sounds like you have a handwritten protocol execution process that you want to streamline for business reasons. If that’s the case, then I recommend one of two paths: either 1) Continue to execute your protocols by hand and improve your document scanning/imaging capability, or 2) go totally electronic with a validated system like ValGenesis. I would not recommend using a transcription process because it’s costly and you still have to maintain the original record.
