Q&A 24 : Does validation and compliance apply to the use of Adobe for the creation of electronic signatures?

“During the discussion surrounding electronic data and ensuring validation, compliance to 21cfr11, etc.. does this requirement apply to the use of Adobe for the creation of electronic signatures? Adobe is not validated.. this is why I ask.”

ICH GCP Ref: 1.65 ; 5.5.3

It depends on how Adobe is being used, if it is stated in process that you are using electronic signatures for control documents and these e-signed documents will be part of your ‘system of record’, if this is implemented through Adobe, this would not fulfil the requirements of electronic signatures or validation. Documents generated through this processes would therefore not be considered to meet the requirements of electronic signatures or control, and would not be considered source or system of record.

    Tammy Finnegan, COO tammy.finnigan@tritrials.com

Click here to see all the Q&As