eSign News

21 CFR Part 11 Compliance

Signatures play a critical role in CFR (Code of Federal Regulations) compliance, especially in regulated industries such as pharmaceuticals, biotechnology, medical devices, and food manufacturing. The most relevant CFR for signatures is 21 CFR Part 11, which governs electronic records and electronic signatures used by the U.S. Food and Drug Administration (FDA).

Signatures are important in CFR compliance for a variety of reasons:

1. Authentication and Accountability.
   Signatures identify who performed a particular action or approved a document, which is important to ensure traceability and accountability within regulated processes, helping organizations prove compliance during audits or inspections.
2. Legally Binding
   21 CFR Part 11 defines an electronic signature as legally equivalent to a handwritten signature, ensuring that approvals, reviews, and authorizations are enforceable and binding under law.
3. Audit Trail Integrity
   Signatures contribute to maintaining a secure audit trail, which is essential for showing who, what, when, and why an action was taken in a regulated system.
4. Verification of Intent
   Signing a document or digital record shows that the individual intended to endorse or approve the content. This helps ensure the integrity and trustworthiness of records used for quality control, clinical trials, or regulatory submissions.
5. Security Controls
   Under 21 CFR Part 11, organizations must implement strict controls to ensure signatures can not e forged or misused. Safeguards include unique user IDs and passwords, two-factor authentication and time-stamped signature logs.
6. Document Lifecycle Control
   Signatures often mark key points in the document lifecycle: draft, review, approval, release. This control ensures documents (like SOPs, batch records, or clinical data) are reviewed and authorized appropriately.

The top 5 systems known for CFR Part 11–compliant electronic signatures are:

• DocuSign
• Adobe Acrobat Sign
• MasterControl
• Veeva Vault
• TrackWise Digital

For businesses that use Atlassian Jira or Confluence, the following solutions can be integrated with those apps to add workflow control, approvals and Part-11 compliant signatures:

• eSign for Confluence 
• Comala Document Management (for Confluence)
• eSign for Jira 
• Valiantys eQMS for Jira
• eSign Document Management & Training

For companies dealing with electronic systems, ensuring your e-signatures comply with 21 CFR Part 11 is essential, since non-compliance can lead to FDA warnings, product recalls, or loss of market access. The use of tools and apps to assist with compliance can be a great benefit to any organization.