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.