Ensuring Electronic Signature Licitness for Employee Compliance Survey in United States

How to eSign a document: electronic signature licitness for Employee Compliance Survey in United States

hey everyone lua here with another tutorial video from kamal attack in this video we'll be talking about how to use kamala document management to add electronic signatures to confluence that are critical in complying with the fda's cfr 21 part 11. today i'll be showing the data center server version of confluence but we also have a video on using electronic signatures in the cloud which i'll link to below before we dive into confluence let's quickly review some of the criteria the fda requires for electronic signatures if you'd like a complete guide to cfr21 part 11 compliance and confluence we have a full compliance statement and guide on our wiki and i've linked to that below as well for now we'll just stick to eSignatures the first section we'll look at is 11.50 a which says signatures need to have the name of the signer the date and time when the signature was executed and the meaning associated with the signature let's see how each of these points are covered with the electronic signatures available in kamala document management so here i have a sample page with a workflow applied and we can see the workflow requires an electronic signature there's a field to enter the printed name that's the first requirement and you can set it to require either a one-time authentication or a password in this instance i've chosen to just use a password so once i've entered my information i can approve or reject the page for the next requirement the date and time we can go to the activity report this report shows all workflow activity in our document including the time the date and the sign name of the person who gave the approval the final requirement is something that shows the meaning of the signature in our workflows you have the ability to name a specific approval so this approval we just did was called review confirmation and we can see the name in the activity report here so that covers 11.50 a but that's not the only thing the fda mandates 11.50b requires that all the information about the signature we just looked at is included in the electronic record and also in any hard copy version of the document we already know that we can view the page activity but we can also embed the activity right into the page itself with a simple macro so we'll just edit the page and insert the page activity macro now we can update our page and we'll see that the activity report has been embedded right into the content of the page itself so if we need to export it as a pdf or print it off in some way the activity report will be there in the hard copy version now that you've seen how the electronic signatures in kamala document management can fulfill fda regulations i'll quickly show you how to set one up i'll go to a new page and i'm going to add a workflow i'm just going to choose the simple approval workflow for this example but you can choose a different template or create your own custom workflow from scratch i'll click apply and customize which brings me to the workflow builder here i can see my workflow and edit it i'll choose the state that i want to add my eSignature to and select the approval here i can edit the name of my approval as we discussed earlier i also have options on how to assign the reviewers this is where i can put in a specific name and then down under advanced this is where you can actually turn on the electronic signature once i've set up my settings i'll apply and save now i can go back to my page and click on the workflow and you'll see that the a signature has been applied well that's a quick run through of setting up an electronic signature and confluence and how it can meet the requirements of fda cfr 21 part 11. if you have any questions we have the compliance statements in our wiki for a complete guide or you can contact our support team thanks for watching and have a great day