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

Uniting Tech Giants | DocuSign for Atlassian

By Praecipio Consulting on Apr 21, 2017 11:00:00 AM

By Tony Mann (DocuSign)
Shared from the DocuSign Blog  

An interview with Steven Kling,

Principal of Product Development at Praecipio Consulting

With DocuSign Momentum fast approaching, we sat down with Steven Kling, Principal of Product Development at Praecipio Consulting – makers of DocuSign for Atlassian – to learn about the experience of building a DocuSign integration and what he’s most looking forward to at this year’s Momentum conference.

Q: Tell us about what led Praecipio Consulting to build a DocuSign integration?
A: We use DocuSign extensively at Praecipio Consulting. From Statements of Work to contracts in our Sales team, to everything internally from HR to Legal. As an Atlassian Platinum Solution Partner, we use their suite exclusively for all of our processes, so an integration is something we wanted ourselves for Atlassian’s Confluence collaboration platform. We’re the experts in JIRA, Atlassian’s industry-dominating business, software, and service desk management platform, and we saw a huge potential market for regulatory compliance (FDA, SOX, etc) that required repetitive, signatures; especially given the various digital initiatives out there pushing adoption.

Q: What was the development process like?
A: I’m a veteran of many various integration efforts over the years; some more successful than others. One key factor is a strong partnership. DocuSign provided solid and reliable technical assistance the few times it was necessary to reach out. Nobody has a perfect API, but DocuSign’s is as close as I’ve seen with excellent documentation and a testing UI that made familiarization easy. It’s definitely one of the most well designed products I’ve worked with from an integration perspective.

Q: What lessons did you learn during the process that you can share with other people looking to build a DocuSign integration?
A: We learned a great deal about Adobe PDF, CSS and multipart http requests! We had thought we could rely on Atlassian’s bundled export utilities but these were not exposed APIs and we had to come up with our own export-to-PDF solution. It’s not something we had counted on. So make sure you know if the product you’re integrating with can hand you a pdf, or start cracking the books. As for multi-part http posts, we were caught between versions of Apache’s http offerings with wildly differing APIs for multi-part, which is required for sending documents. If you’re using Java you’re likely to use Apache, so go with the latest 4.5.x HttpComponents and be wary of which version when looking at examples and online documentation.

Q: What are the use cases and types of teams that can benefit from DocuSign for Atlassian?
A: We’ve got a suite of products to make any team that relies on signatures much more efficient and provide consistent traceability, built seamlessly into the Atlassian applications they use every day. My favorite example is an HR recruiter. Each new hire goes through stages of the hiring process that require signatures, but also captures a lot of personal information. Today’s standard at best is a repetitive set of documents sent via PDF in email attachments that, best case, are fillable but more typically must be printed, filled out, signed and scanned. The same information: Name, Address, Phone, SSN, etc entered each time. Depending on the HR team’s process, these will get saved to a share network drive or worse, printed and left on a desk or an unlocked filing cabinet. With DocuSign for JIRA, each needed document is sent automatically as the prospect’s JIRA is moved through the new hire workflow. Each DocuSign field (tab) filled in is captured as a JIRA field that can then populate subsequent documents further in the process and even on into the on-boarding tickets post-hire. Of course there are other use cases for Release Management, SOX Compliance, FDA CFR21 Part 11, Legal, and Sales – but the HR recruiter is as solid a value proposition I’ve seen. And its totally customizable to your current process. No major culture changes required!

Q: What can we look forward to seeing from you at Momentum 2017?
A: Well, on the developer track I’m going to focus on two things: First, a review of the use cases from requirements sign-off to release management for enterprise development teams and how DocuSign for Confluence, DocuSign for JIRA and DocuSign for HipChat (coming soon) can automate approvals and ensure traceably through the development life cycle. Then I’ll go into lessons learned, reviewing some of the technical challenges of integrating with DocuSign. I don’t think anyone has flexed the muscles of the DocuSign APIs as much as our team and we’re happy to pass on what we’ve learned!

See you at Momentum 2017

Make plans to catch Steven Kling’s presentation, Uniting Tech Giants: DocuSign for Atlassian (Thursday, May 4th at 10:00 AM – Developer Track) to learn more about how DocuSign for Atlassian can transform your approval processes, and to learn their best practices for DocuSign API integration.

Topics: atlassian blog docusign
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

Praecipio Consulting is an Atlassian Platinum Partner

This means that we have the most experience working with Atlassian tools and have insight into new products, features, and beta testing. Through our profound knowledge of Atlassian environments and their intricacies, we can guide your organization as you navigate these important changes.

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