🖊 How to Sign a Document using a Digital Certificate in Spain

[@Thomas140]

Just curious to know, does it compliance with 21 CFR Part 11? I can find that Adobe Sign did compliance with it, but this will need to pay. But how about this method?

[@entretramites-en]

Hello! In response to your question, it's important to note that the method I demonstrated in the video using Adobe Acrobat to sign the PDF document may not inherently guarantee compliance with 21 CFR Part 11 as achieving it requires more than just the usage of a certain program/software. If your organization operates in an FDA-regulated industry and requires full compliance with 21 CFR Part 11, it's essential to carefully review and assess the entire process, like the security of your digital certificate, data integrity, user authentication mechanisms, etc. You can check your organization's compliance or consult with its IT department to ensure full compliance when signing any document. And yes, Adobe Sign is explicitly designed to meet regulatory compliance requirements, including the one you mentioned, but as you say it comes with associated costs.