12/8/2023 0 Comments Adobe sign![]() Below are two documents that may be provided to sponsors with questions about part 11 compliance. ![]() This was determined by DHTS to meet the requirements of an “Electronic Signature” under part 11 as long as we’re working with entities that Duke has a business relationship with. We require the use of Duke/Corporate email addresses that require log in with a network ID, thus validating the signer. Instead, we use the more generic “Electronic Signature”. Register Part 11 Compliance Documentation and DHTS SOPs:ĭHTS’s Adobe Sign instance is not configured for “Digital Signature”, which is a specific type of electronic signature that uses higher-level encryption and requires a third party to certify you are who you say you are for a fee, similar to a notarized signature. Differentiate between e-signatures and digital signatures.Describe how you can and cannot use Adobe Sign.This training is intended for clinical research personnel at Duke who will request access for Adobe Sign from the Duke Office of Clinical Research. Adobe Sign Training for Clinical Research | DOCR | 00147697 When you are ready to use Adobe Sign follow this link to get there. If you need an account, complete the training below and then request one by completing the form found here. In order to create and send documents with Adobe Sign, you will need to have an account. Documents will be permanently purged and recovery will not be possible. This policy will remain in effect in perpetuity. Thirty days after a document is completed (signed by all parties necessary) it will be automatically and permanently purged from the Adobe Sign storage cloud. No software is needed for signers (who can be internal or external to Duke, provided no PHI is being sent).ĭHTS has implemented a 30 day document retention policy effective November 5th, 2020. Use a modern browser to prepare, send, sign, track, and manage signature processes. With the secure Adobe Sign cloud-based app, you replace paper and ink signature processes with fully automated electronic signature workflows. Summer Undergraduate Research OpportunitiesĪ change was made a few weeks ago to our group settings in Adobe Sign to facilitate 21 CFR Part 11 electronic signature compliance (Bio-Pharma). In order to self-sign, you will need to route your document to yourself for signature, rather than signing as you have been.Duke Research and Discovery Core Facilities & Service Centers.However, units exceeding 500 annual transactions may be assessed a fee at the end of the fiscal year. In most cases, there is no charge for using Adobe Sign. A separate Acrobat Pro DC or Creative Cloud license is required to install Acrobat on your device.Īdobe Sign usage is measured by the number of transactions made per year, per unit.Requirements for Acrobat DC can be found on Adobe’s Acrobat System Requirements page. Integration with Adobe Acrobat requires Acrobat DC to be installed on your computer or mobile device.Supported browsers can be found on Adobe’s System Requirements page. Adobe Sign requires a web browser for signature collection and management.See the Adobe Status portal for current service status and past incidents. Record a transaction audit trail for each documentĪdobe Sign is a cloud hosted solution, for which Adobe promises 99.9% uptime.Create and share document templates with your team.Designate recipients as signers or approvers.Request signatures from multiple recipients, in any order, a specific order, or a combination of both.Invite signers to complete documents via through email, even if they don’t have an Adobe ID.And because Adobe Sign is integrated with your existing BU login, you won’t need to create and track external accounts. Efficiently and securely send documents for signature without requiring recipients to print and scan. BenefitsĪdobe Sign makes it easy for individuals or departments to build, send, and track forms for digital signatures. See Cost, below.Īdobe Sign provides secure, comprehensive e-signature collection and automation from anywhere, including Adobe Acrobat and Microsoft Office.
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