The document describes a JIRA add-on that provides e-signature and audit reporting capabilities to comply with FDA CFR Part 11 regulations. The add-on adds an e-signature field to the JIRA workflow where users must authenticate before transitioning an issue to the next stage. It also provides an audit report with user names, dates, and timestamps of e-signatures that can be printed from within JIRA. The add-on comes with a free 30-day trial and is designed to integrate seamlessly with JIRA.

1. Professional Add-ons for
Atlassian JIRA, Confluence, Crowd,
Stash, Bamboo, FishEye, Crucible
CFR Part 11 E-Signatures (FDA Compliance)
in Atlassian JIRA®
www.appfusions.com

2. CFR Part 11 E-Signatures (FDA Compliance) for JIRA adds an e-signature JIRA field and
audit reporting to your workflow. It is for corporations or organizations requiring Title
21 CFR Part 11 compliance.
E-Signature field added to JIRA workflow
• Audit reports including names, date, time (hour/minute/second) details - printable
view of all E-Signatures
• New "E-Signatures" tab in the "Activity" section for each issue
• User re-authenticates at each key stage to sign the transition
• Only successful authentication allows transition to next stage
Overview
CFR Part 11 E-Signatures (FDA Compliance) for Atlassian JIRA

3. Custom E-Signatures Field
 Require E-signatures for workflow steps
CFR Part 11 E-Signatures (FDA Compliance) for Atlassian JIRA

4.  Verify user information before next step
Validation Window
CFR Part 11 E-Signatures (FDA Compliance) for Atlassian JIRA

5.  Record of user activities and times
E-Signature History Tab in JIRA
CFR Part 11 E-Signatures (FDA Compliance) for Atlassian JIRA

6.  Detailed information for auditing and internal use, launched from inside JIRA
Printable Report
CFR Part 11 E-Signatures (FDA Compliance) for Atlassian JIRA

7. And many more…
CFR Part 11 E-Signatures (FDA Compliance) for Atlassian JIRA
Sampling of Our Customers

8. These are packaged “plug and play” integrations that are developed,
supported, and continually sustained by AppFusions. Our add-ons and
authenticators are installed in small and large corps, world-wide.
Free 30-day trials.
Request a license key at info@appfusions.com
Visit www.appfusions.com for more info!
Thank you!
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9. info@appfusions.com +1 (888) 516-2890 @appfusions