FDA 21 CFR Part 11 with Confluence
Capable Approvals for Confluence enables regulated teams to manage approvals for electronic records with traceability, auditability, and accountability—making it a valuable part of a compliant strategy for FDA 21 CFR Part 11. This article maps how Capable helps with each regulatory requirement outlined in Subparts B and C of the regulation.
✉️ What Is FDA 21 CFR Part 11?
FDA 21 CFR Part 11 is a regulation from the U.S. Food and Drug Administration that sets the ground rules for using electronic records and electronic signatures. It applies to any FDA-regulated organization using systems like Confluence to manage documentation such as SOPs, policies, quality records, and validations.
To comply, systems must:
Ensure electronic records are trustworthy and reliable
Limit access to authorized individuals
Maintain secure audit trails
Use electronic signatures that are legally equivalent to handwritten ones
✅ Capable Approvals Compliance Checklist
The table below breaks down specific FDA requirements and how Capable Approvals, when configured correctly within Confluence, supports compliance.
Regulation | Requirement | How Capable Approvals Helps |
|---|---|---|
11.10(a) | System validation to ensure accuracy and performance | Capable is built on Forge and designed with auditability and traceability in mind. Validation procedures can be implemented internally as part of your QMS. |
11.10(b) | Generate complete and human-readable records | Approval data is visible directly on Confluence pages. Pages can be exported to PDF/Word and include approval logs. |
11.10(c) | Protection of records and retention | Approvals are embedded in Confluence, which has version history and permissions. Content is retained according to your workspace's retention policies. |
11.10(d) | Limit access to authorized individuals | Capable inherits Confluence access control and permissions. Only permitted users can send or respond to approvals. |
11.10(e) | Secure, time-stamped audit trails | All approvals include timestamps, user identity, status, and comments, stored as part of the page record. This information cannot be modified after submission. |
11.10(f) | Operational checks for sequencing of steps | You can configure approvals to follow a specific workflow sequence, ensuring policies or procedures are reviewed in the correct order. |
11.10(g) | Authority checks to prevent unauthorized action | Only page editors or authorized approvers can initiate or complete approvals. All actions are logged. |
11.10(i) | Training and experience of users | Teams should document training on Confluence and Capable use. Capable offers an intuitive UI to reduce training time. |
11.10(k) | Control over system documentation | Approval workflows can be used to manage operational documentation. Page restrictions and versioning control access and edits. |
11.50(a-b) | Signature includes name, timestamp, and meaning | Each approval shows who approved it, when, and for what purpose (e.g., Review, Approval). Data appears in the Confluence page UI and exports. |
11.70 | Signature must be linked to its record | Capable ensures approvals are stored with their respective Confluence page and cannot be separated or falsified. |
👉 Subpart C – Electronic Signatures
Capable Approvals does not currently implement password-based e-signatures or multi-factor authentication as required by Subpart C. However, it supports audit-ready approval trails, and you may combine it with identity verification policies in your infrastructure.
Regulation | Requirement | How Capable Approvals Helps / Considerations |
|---|---|---|
11.100(a) | Signature must be unique | Capable uses Confluence identity (email) for approvals. Admins should ensure user accounts are not shared. |
11.100(b) | Identity verification | Organizations must verify user identity before granting Confluence access. |
11.100(c) | Certification of signature use | Customers must document the use of electronic signatures and submit the required certification to FDA. |
11.200(a)(1) | Two-factor authentication for signing | Not currently supported natively in Capable. Can be supported by securing Confluence logins with SSO or MFA. |
11.200(a)(3) | Signature use by genuine owners only | Customers must enforce account and credential security policies. |
11.300(a-e) | Safeguards for ID/password systems | While Capable doesn’t issue passwords, Confluence user security settings and policies must cover these safeguards. |
💡 Best Practices for Using Capable Approvals in FDA-Regulated Environments
Restrict approval actions to trained and authorized users using Confluence permissions.
Export Confluence pages with approvals for audits and reviews.
Establish internal SOPs for managing Capable workflows.
Use Confluence versioning and retention settings to align with FDA expectations.
Ensure identity and signature policies are in place to complement Capable's capabilities.
🌐 Summary
Capable Approvals helps regulated teams build compliant approval workflows in Confluence with detailed tracking and change management. While Capable does not cover all electronic signature-specific requirements of Part 11 Subpart C, it offers a strong foundation for compliant documentation and approval processes in electronic recordkeeping environments.
For full compliance, Capable should be used as part of a broader validated QMS that includes identity verification, access controls, system validation, and employee training.