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This reference table highlights the features and capabilities of the eSign Document Management (eDoc) app for Confluence. See the full User Guide for more information.
Document Review and Approval | Review and approve documents with the robust and proven eSign electronic signature engine. Signature verification confirms record integrity and that all approvals are valid and content/attachments were not changed after signing. Customizable approval templates with multiple signature meanings allow reviews to can be assigned to specific reviewers (e.g. QA Approval, Compliance Review, etc). Generate printable Approval Record reports at any time for audit and inspections
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Document Workflow | Document workflow guides users through the document process and supports quality system requirements. Reviewers receive email Invites to review documents. Reviewers can approve or reject each revision with feedback. Document workflow configurable at the space level.
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Document Control | Document Control ID’s and Revision numbers to effectively track documents. Document owners can provide corporate doc control ID’s and revisions numbers or allow eDoc to generate unique ID’s and Revisions. eDoc will automatically lock approved and released revisions to prevent editing. eDoc Byline and optional Document Header macro communicates state of every document revision (DRAFT, IN REVIEW, FINAL, ACTIVE, OBSOLETE).
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Document Release and Publishing | Release workflow includes integrate publish feature to copy approved documents to a separate controlled Space for end user training and reference. This feature allows the Original document to be authored for subsequent revisions without impacting users training/referencing the currently Active document. Feature included in eDoc; no separate app required.
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Document Training | Manage user document training (e.g. Read & Understood, Read Confirmations) Assign users to train on new document revisions Users complete training with electronic signatures Generate printable Training Record reports at any time for audit and inspections Feature included in eDoc; no separate app required.
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Document Search | Interactive search and saved search macro available. Find and display related documents by Document Control ID. User Search Macro to power index pages that display only Active document revisions.
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Audit Log | Comprehensive audit log retained by eDoc for all document control activities Generate a printable Audit Record report at any time for audits and inspections Assist customers in achieving compliance with standards like ISO 9001 and ISO 13485
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Signature Execution
| Designed to meet FDA CFR Part 11 requirements for electronic records and signatures (See US FDA Part 11 Electronic Signature Assessment ) TODO Multi-factor authentication with personal Signature Pins in addition to Atlassian Cloud security. Personal Signature Pins are persistent and reusable to optimize usability. No waiting for a OTP (one time password) to be sent every time a user needs to sign something.
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Signature Manifestations | Capture User Name, Date/Time and Meaning of each Signature. Capture e-mail and Atlassian account ID for non-repudiation. (This is necessary for electronic record compliance as Atlassian users may alter their display name) Signatures dates and times reflect and local time zone of each document. Capture of Titles. User Titles are saved for reuse and usability. Signature meanings are configurable.
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Signature Integrity | Signature verification for record integrity and automatically detects if the content was changed since the signature was captured. Verification included in Approval Record report. Print/Save to PDF. Comprehensive audit trail of all signature activity.
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Security and Infrastructure | |
Configuration | Configure allowable document, workflow and approval options for each Space. Document administration functions restricted to Owners and Space Administrators.
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