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Digital Signatures

NirmIQ provides FDA 21 CFR Part 11 compliant digital signatures for electronic records, enabling regulated industries to maintain legally binding approval workflows.

Overview​

Digital signatures in NirmIQ:

  • Authenticate the signer's identity
  • Capture the meaning of the signature
  • Ensure content integrity with cryptographic hashing
  • Provide complete audit trails
  • Support multi-signature approval workflows

Regulatory Compliance​

FDA 21 CFR Part 11​

NirmIQ's digital signatures comply with:

SectionRequirementHow NirmIQ Complies
11.50Signature manifestationsCaptures signer name, date/time, and meaning
11.70Signature/record linkingSHA-256 hash binds signature to content
11.100General requirementsUnique user ID, password verification
11.200Electronic signature componentsPassword re-authentication required

Other Standards​

Digital signatures also support:

  • ISO 13485 - Medical device quality management
  • IEC 62304 - Medical device software lifecycle
  • DO-178C - Aerospace software certification
  • ISO 26262 - Automotive functional safety

Signature Types​

Approval​

Used when formally approving a document or requirement for the next phase.

Example meanings:

  • "I approve this requirement as technically correct and complete"
  • "Approved for implementation"

Review​

Used when completing a formal review without final approval authority.

Example meanings:

  • "I have reviewed this requirement for accuracy"
  • "Technical review completed"

Release​

Used when authorizing release to production or external parties.

Example meanings:

  • "I authorize the release of this artifact"
  • "Approved for customer delivery"

Verification​

Used when confirming test completion or verification activities.

Example meanings:

  • "I verify that testing has been completed per requirements"
  • "Verification activities completed successfully"

Acknowledgment​

Used when confirming receipt or understanding.

Example meanings:

  • "I acknowledge receipt and understanding of this document"
  • "Training completed"

Signing a Document​

Step 1: Open the Item​

Navigate to the requirement, FMEA analysis, or document you want to sign.

Step 2: Click Sign​

Click the Sign button in the toolbar or detail panel.

Step 3: Select Signature Type​

Choose the appropriate signature type (Approval, Review, etc.).

Step 4: Enter Meaning​

Select from predefined meanings or enter a custom statement describing what your signature represents.

Step 5: Re-authenticate​

Enter your password to confirm your identity. This is required for every signature per FDA 21 CFR Part 11.

Step 6: Confirm​

Click Sign to apply your digital signature.

Viewing Signatures​

On an Item​

Open any signed item to see:

  • List of all signatures
  • Signer name and role
  • Date and time
  • Signature meaning
  • Verification status

Signature History​

View the complete signature audit trail:

  1. Open the item
  2. Click Signatures tab or icon
  3. Review chronological list

Verifying Signatures​

NirmIQ automatically verifies signature integrity:

Verification Checks​

  • Content unchanged: Hash comparison confirms no modifications
  • Signature valid: Signature has not been invalidated
  • Signer authenticated: Original authentication was successful

Verification Status​

  • ✅ Valid: Content unchanged since signing
  • ⚠️ Modified: Content has changed - signature may not apply to current version
  • ❌ Invalid: Signature has been administratively invalidated

Manual Verification​

To manually verify a signature:

  1. Open the signed item
  2. Click Verify Signatures
  3. Review verification results

Multi-Signature Workflows​

For items requiring multiple approvals:

Sequential Signatures​

Signatures must be applied in order (e.g., Engineer → Lead → Manager).

Parallel Signatures​

Multiple signers can sign independently.

Workflow Status​

Track approval progress:

  • Pending: Waiting for signatures
  • In Progress: Some signatures collected
  • Complete: All required signatures obtained

Administrator Functions​

Invalidating Signatures​

Administrators can invalidate signatures when necessary:

  1. Navigate to the signed item
  2. Click Manage Signatures
  3. Select the signature to invalidate
  4. Enter reason for invalidation
  5. Confirm

Note: Invalidation is logged and the signature record is preserved for audit purposes.

Signature Templates​

Create organization-wide signature meanings:

  1. Go to Admin → Signature Settings
  2. Click Add Meaning Template
  3. Enter:
    • Template name
    • Meaning text
    • Applicable signature type
    • Entity types (requirement, FMEA, etc.)
  4. Save

Best Practices​

1. Use Consistent Meanings​

Use predefined signature meanings for consistency across the organization.

2. Sign Promptly​

Sign items when review is complete to maintain accurate records.

3. Verify Before Signing​

Ensure you've thoroughly reviewed content before applying your signature.

4. Document Changes​

If content must change after signing, document why and obtain new signatures.

5. Regular Audits​

Periodically review signature compliance and completeness.

Integration with Workflows​

Digital signatures integrate with:

  • Requirements approval - Sign off on requirement baselines
  • FMEA reviews - Approve failure mode analyses
  • Design reviews - Capture design approval decisions
  • Test completion - Verify test execution

Audit Reports​

Generate signature audit reports:

  1. Go to Analytics → Compliance Reports
  2. Select Signature Audit
  3. Choose date range and scope
  4. Export as PDF

Reports include:

  • All signatures applied
  • Verification status
  • Any invalidations
  • Unsigned items requiring signatures