5 min read

Simplify FDA eSignature requirements in Atlassian Jira

By Brian Nye on Jan 22, 2019 11:40:00 AM

What is FDA 21 CFR Part 11?

FDA 21 CFR Part 11 regulation (Part 11) is the Food and Drug Administration's regulations that cover document signing and records retention for processes and documents specified by the FDA. Prescribed as an “open system” system solution, as defined in Section 11.3(b)(9), in which there is electronic communication among multiple persons and where system access extends to people who are not part of the organization that operates the system. The controls for an open system are discussed in Section 11.30.

...the system shall employ procedures and controls designed to ensure the authenticity, integrity and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt to ensure record authenticity, integrity and confidentiality.

To help meet the control requirements, DocuSign’s Part 11 module has pre-set account options to add, authenticate and limit envelope access to authorized signers. 

DocuSign's Part 11 Module: Designed for Ensured Compliance

DocuSign sets the global standard for electronic signatures and Digital Transaction Management (DTM) and supports life science organizations’ compliance with the e-signature practices set forth in 21 CFR Part 11 with tailored functionality and packaged service offerings. DocuSign’s open, standards-based approach makes it easy to integrate compliant electronic signatures, even into complex processes and systems.

DocuSign Part 11 Module available with DocuSign Enterprise delivers transactions guaranteed to meet all FDA regulations. It contains capabilities designed specifically for the Life Sciences industry that include:

  • Signature-level credentialing
  • Signature-level Signature Meaning
  • Pre-packaged account configuration
  • Signature manifestation (Printed Name, Date/Time, and Signature Meaning)

Automating Compliance Into Your Workflow

For organizations that use Jira to manage their business processes, DocuSign for Jira makes it easy to integrate and automate DocuSign-guaranteed compliance directly into your Jira workflows. For Life Science and other industries that must comply with strict FDA regulations DocuSign for Jira is a must. DocuSign for Jira is specifically designed to work with your existing DocuSign template libraries so you can automate the sending of critical, government-regulated documentation at each stage of your business process that requires official sign-off.

Map Your Recipients to Jira Issue Fields & Roles

In each transition you can specify variables from Jira issue fields, roles or identify static Jira users and email addresses to map to the DocuSign's envelope recipients. This can be done using Template Schemes where Jira Issue Types can be mapped to DocuSign Templates and recipient roles mapped as well. Or Jira administrators can identify specific templates, recipient and field mappings directly into workflow transitions for greater flexibility.

Pre-Fill Your DocuSign Documents with Jira Data

The sign-off process involving official, regulated documentation can be data-entry intensive. Often this is done by manual document creation, then further manual uploads to DocuSign via Word .docx or Adobe .pdf files that are then decorated with initial, signature and other DocuSign tabs.  Though DocuSign provides a robust field definition and configuration capability, this often goes unused beyond capture of necessary inputs for the document itself. Reporting, querying or re-use of the valuable data entered during envelope signing is not possible. DocuSign for Jira allows fields 

Capture Your DocuSign Recipient Data Entry in JIra Fields

DocuSign for Jira supports bidirectional or "two-way" synchronization between DocuSign "Tabs" and your Jira issue fields allowing capture and reportable persistence of all information and corrections gathered during the signing processes. If your recipients are external to your organization and not users in your Jira instance, you can still capture their data inputs from DocuSign envelopes using the "Delegate Edit" feature. This capability is particularly useful in cases where multiple documents are filled/signed in a process where subsequent documents rely on previous 

Manage DocuSign Envelopes from Jira

Your employees who rely heavily on DocuSign and Jira to perform their daily functions and duties will find links and information at their fingertips from within their Jira issues or in DocuSign for Jira's Project Report. Filter by Envelope Title, Sender, Status and sort as well. View recipient-level status as well by expanding the rows. Each issue has a new DocuSign Envelopes pane as well as a DocuSign audit tab for quick, easy access to envelopes and important, audit events.

 

Automate and Simplify

DocuSign Enterprise CFR Part 11 Module guarantees thorough compliance with FDA regulations. DocuSign for Jira takes that full capability and DocuSign's carrier-grade infrastructure and combines it with Jira's world class business process management application to automate the review, approval and signature processes that require the utmost confidence in security, retention, audit and repeatability. With DocuSign for Jira's unique template-based mapping system, you can capture all your data inputs from the signature process in DocuSign in to Jira for reporting and reuse.

To learn more about DocuSign for Jira, take a look at our demo video or contact Praecipio Consulting to help your organization automate your eSignature process.

Topics: jira regulation compliance docusign fda
3 min read

How to Expedite Approvals with DocuSign for Confluence

By Praecipio Consulting on Aug 4, 2016 11:00:00 AM

According to IDC's 2015 report, The Document Disconnect, 76% of executives and managers in sales, HR, procurement, legal, and other departments estimate that fixing the “document disconnect” can lead to document process issues impact revenue recognition or create auditor issues. As process improvement experts, we at Praecipio Consulting love saving our clients money by mitigating wasted time and helping them do work faster. With that in mind, we've compiled our top 4 tips to get faster approvals leveraging DocuSign for Confluence to integrate your mission critical document tools. 

1. Maximize Your Macros 

Confluence macros add significant value to your document drafting process with their features and functionality. Just select from your macro options and voìla - your desired information appears! By utilizing the out-of-the-box DocuSign for Confluence macros, you can simply drop the macro for your DocuSign tabs (ex. signature, initials, date, title, and more!) into your document right inside of Confluence. Adding this functionality to your document drafting allows you to save time otherwise spent selecting and adding these approval actions outside of Confluence, and also ensures that your document collaborators can see the macros you're adding and where.

Select from the menu of macros to inform your signee of what do provide.

2. Template-ize It! 

Think of the documents you create the most frequently. From sales and marketing to HR and legal, every department has documents that need signatures and approvals on a daily basis (often multiple times a day). Save your team countless hours by creating Confluence templates for these frequently used documents and reduce unnecessarily wasted time. Your Space administrator can add these templates (including the aforementioned DocuSign macros) to your instance, in the spaces you need them, so you can now spin up your next contract with the click of a mouse. 


In Confluence, click 'Create' and get prompted with both custom and out-of-the-box templates.

3. Streamline Sending 

It's simple logic: the faster you send your document, the faster you can get approvals. However, cumbersome sending processes can keep you from firing off that contract as quickly as you'd like. Leverage DocuSign for Confluence to send documents from Confluence (including all the attachments and pages your heart desires) to not one, not two, but as many recipients as you want! Set action type and order in this same step to determine who needs to sign, who needs to receive a copy, and the sequence in which these actions will occur. 

When adding recipients inside your organization, names are pulled from your Confluence user directory so you can send even faster.

4. Track in Real-Time  

Being able to see where your document is in the approval process is invaluable when you're waiting for that proverbial ink to dry. DocuSign for Confluence provides real-time status notifications so you can track your documents, from sending to completion. By simply clicking the DocuSign lozenge at the top of your Confluence page, you see what stage your document is in and who has completed what action. Additionally, clicking the status to see approval actions on the document in DocuSign. This level of visibility allows you to see when you're DocuSign envelope has been created, sent, and signed to give you the most accurate document tracking. 

View the status of all your DocuSign Envelopes in one streamlined view.

Improving processes relies heavily on cutting our unnecessary intermediary steps that can become blockers. It's these steps that, unchecked, can cost a company thousands of hours that could otherwise be spent focused on core competencies. As process experts, we recommend to all our clients- from 20 person startups to Fortune 5 enterprises- to ask themselves the following questions regarding their processes:

  • Can it be repeated? 

  • Can we automate it?

  • Can we eliminate unnecessary steps?

By optimizing your repeatable e-signature processes with DocuSign for Confluence, your organization not only saves time, but also reduces document processing issues that cut into profit or jeopardize compliance with auditing agencies. 

Ready to expedite your e-signatures? Get DocuSign for Confluence and start getting your fastest approvals.

Topics: atlassian blog confluence experts hipaa marketplace process-consulting regulation sign service-level-agreement tracking compliance docusign e-signature fda integration productivity atlassian-products marketplace-apps bespoke

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