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Audit, Compliance & Traceability ​

Overview ​

Capture provides comprehensive audit trails and traceability for all human decisions and interactions. This makes it suitable for regulated engineering environments where accountability, compliance, and complete documentation are essential.

Audit Trail Fundamentals ​

What is Recorded ​

Capture automatically tracks and records:

User Actions:

  • Who created the capture
  • Who viewed the capture
  • Who reviewed artifacts
  • Who added markups
  • Who submitted/approved/rejected
  • Who added comments
  • Who modified fields

Timestamps:

  • When capture was created
  • When each action occurred
  • When status changes happened
  • When automation executed
  • Duration of reviews

Decisions:

  • What decision was made (approve/reject/submit)
  • Why (comments and reasoning)
  • What context (artifacts, metadata)
  • What outcome (automation triggered)

Changes:

  • Field value changes
  • Artifact additions/removals
  • Status transitions
  • Metadata updates

Timeline View ​

Accessing Timeline ​

Every capture includes a timeline showing complete history:

  • Chronological list of all events
  • User who performed each action
  • Timestamp for each event
  • Associated comments and data

Timeline Entry Format ​

[Icon] Action Description
       By: User Name (username@domain)
       Date/Time: 2024-01-15 14:35:22
       Details: [Specific information]
       Comments: [If any]

Example Timeline ​

📝 Capture Created
   By: John Smith (jsmith@company.com)
   Date: 2024-01-15 09:00:00
   Details: Created from template "Engineering Review"

📎 Artifacts Added
   By: John Smith (jsmith@company.com)
   Date: 2024-01-15 09:02:15
   Details: 3 files added: DWG-001.dwg, DWG-002.dwg, DWG-003.dwg

✉️ Notification Sent
   By: System
   Date: 2024-01-15 09:02:30
   Details: Email sent to reviewer@company.com

👁️ Capture Viewed
   By: Jane Doe (jdoe@company.com)
   Date: 2024-01-15 14:30:00
   Details: Reviewer opened capture

🔍 Review Opened
   By: Jane Doe (jdoe@company.com)
   Date: 2024-01-15 14:35:00
   Details: Review environment opened

✏️ Markups Added
   By: Jane Doe (jdoe@company.com)
   Date: 2024-01-15 14:42:18
   Details: 2 markups added on DWG-001.dwg

✅ Capture Approved
   By: Jane Doe (jdoe@company.com)
   Date: 2024-01-15 14:45:00
   Details: Approved with comments
   Comments: "Approved for release. Minor suggestions noted in markups."

⚙️ Workflow Triggered
   By: System
   Date: 2024-01-15 14:45:05
   Details: On-Approve workflow "Publish Drawings" started

📧 Notification Sent
   By: System
   Date: 2024-01-15 14:45:10
   Details: Approval notification sent to jsmith@company.com

Accountability ​

User Identity ​

Every action records:

  • Full user name
  • Username/email
  • User role at time of action
  • Authentication method

Cannot be anonymized or hidden:

  • All actions attributable to specific users
  • No anonymous reviews or approvals
  • Audit trail cannot be deleted or modified

Role-Based Responsibility ​

Capture enforces accountability through:

  • Role separation - Creators can't approve their own work (if configured)
  • Permission checks - Only authorized users can approve
  • Clear attribution - Timeline shows who did what
  • Documented decisions - Comments required for key actions

Compliance Features ​

Regulatory Compliance ​

Capture supports compliance with:

  • ISO 9001 - Quality management documentation
  • ISO 13485 - Medical device quality systems
  • FDA 21 CFR Part 11 - Electronic records and signatures
  • AS9100 - Aerospace quality management
  • Industry-specific regulations

Electronic Signatures ​

Capture actions can serve as electronic signatures when:

  • User authentication verified
  • Action clearly attributed to specific user
  • Timestamp recorded
  • Intent clear (approve/reject)
  • Cannot be repudiated

Approval = Electronic Signature:

  • User authenticated to system
  • Click "Approve" is intentional action
  • User identity recorded
  • Timestamp captured
  • Decision and reasoning documented
  • Audit trail immutable

Audit Trail Requirements ​

Capture meets typical requirements:

  • ✅ Complete history of all changes
  • ✅ User identification for all actions
  • ✅ Timestamps for all events
  • ✅ Record cannot be altered or deleted
  • ✅ Audit trail accessible for review
  • ✅ Export capability for records retention

Traceability ​

Forward Traceability ​

From capture, trace forward:

  • What happened as a result?
  • What automation executed?
  • What files were published?
  • What notifications sent?
  • What downstream processes triggered?

Example:

Capture #12345 approved
    → Workflow "Publish Drawings" executed
        → Files DWG-001, DWG-002, DWG-003 moved to Released state
        → PDFs published to document control folder
        → Email sent to project team
        → Mesh index updated
        → Calendar event created

Backward Traceability ​

From outcome, trace backward:

  • Why did this happen?
  • Who approved it?
  • What was reviewed?
  • What context existed?
  • What decision was made?

Example:

File DWG-001 in Released state
    ← Released by workflow "Publish Drawings"
        ← Triggered by Capture #12345 approval
            ← Approved by Jane Doe on 2024-01-15
                ← Created by John Smith on 2024-01-15
                    ← Based on design review requirement

Reporting and Analytics ​

Standard Reports ​

Capture supports reporting on:

  • Captures by status
  • Captures by template
  • Approval rates
  • Rejection reasons
  • Review times
  • User activity
  • Process efficiency

Compliance Reports ​

For audits and compliance:

  • All captures in date range
  • Captures by approver
  • Review completion times
  • Stale capture reports
  • Exception reports

Export Capabilities ​

Data can be exported:

  • PDF reports for records retention
  • Excel/CSV for analysis
  • JSON/XML for integration
  • Archive formats for long-term storage

Data Retention ​

Capture Lifecycle ​

Captures persist indefinitely (typical configuration):

  • Created captures never deleted
  • Completed captures remain accessible
  • Timeline preserved permanently
  • Markups and comments retained

Archival ​

For long-term retention:

  • Export captures for archival
  • Include all metadata and timeline
  • Preserve markups and attachments
  • Store in compliance with retention policies

Access to Historical Data ​

Historical captures:

  • Searchable by various criteria
  • Full timeline accessible
  • All original data preserved
  • Audit trail intact

Security and Data Integrity ​

Immutability ​

Audit trail cannot be:

  • Modified after creation
  • Deleted by users
  • Altered by administrators
  • Backdated or future-dated

Ensures:

  • Data integrity
  • Trustworthy audit trail
  • Compliance with regulations

Access Control ​

Audit data access:

  • Role-based viewing permissions
  • Some organizations limit to administrators
  • Compliance officers have full access
  • Users can view their own actions

Data Privacy ​

Personal data in captures:

  • User names and emails recorded
  • Actions attributed to individuals
  • Comments may contain personal observations
  • Privacy policies should address capture data

Audit Scenarios ​

Internal Audit ​

Auditor needs to verify:

  • All design reviews properly approved
  • Approvers had appropriate authority
  • Reviews completed within required timeframes
  • Documentation complete

Using Capture:

  1. Run report: All captures for Q1 2024
  2. Filter: Template = "Design Review"
  3. Review: All captures approved by authorized approvers
  4. Check: Review times within policy (< 5 days)
  5. Verify: All have complete comments and markups
  6. Result: Full audit trail demonstrates compliance

Regulatory Inspection ​

Inspector asks: "How do you ensure drawings are reviewed before release?"

Demonstrate using Capture:

  1. Show template configuration (approval required)
  2. Show role-based security (only senior engineers can approve)
  3. Show example capture timeline
  4. Demonstrate immutable audit trail
  5. Show reports of all releases
  6. Prove 100% review compliance

Quality Investigation ​

Problem: Released drawing had error

Investigation using Capture:

  1. Find capture that approved the drawing
  2. Review timeline: Who approved? When?
  3. Check: What was reviewed?
  4. Examine: What markups were added?
  5. Read: What comments were made?
  6. Determine: Was error visible at review?
  7. Identify: Root cause (missed in review vs not visible)
  8. Action: Process improvement or training

Best Practices ​

Documentation ​

Reviewers should:

  • Add clear, detailed comments
  • Explain reasoning for decisions
  • Document any exceptions or deviations
  • Reference specific issues with markups

Administrators should:

  • Configure templates appropriately
  • Set up reporting for compliance needs
  • Monitor capture completion rates
  • Review audit trails periodically

Process Design ​

Design processes with audit in mind:

  • Clear accountability at each stage
  • Appropriate separation of duties
  • Required comments for key decisions
  • Defined timeframes for reviews
  • Escalation procedures

Training ​

Train users on:

  • Importance of audit trail
  • How their actions are recorded
  • Professional standards for comments
  • Compliance requirements
  • Company policies

Compliance Checklist ​

For organizations with compliance requirements:

  • [ ] Capture audit trail meets regulatory requirements
  • [ ] Electronic signature policy documented
  • [ ] User authentication appropriate for compliance
  • [ ] Audit trail immutability verified
  • [ ] Access controls configured
  • [ ] Reporting capabilities support compliance needs
  • [ ] Data retention policy established
  • [ ] Export/archival procedures defined
  • [ ] User training on compliance aspects completed
  • [ ] Regular audit trail reviews scheduled
  • [ ] Integration with quality management system
  • [ ] Backup and disaster recovery for capture data

Troubleshooting ​

Missing Timeline Entries ​

Should not occur:

  • Timeline is automatically generated
  • Cannot be manually edited or deleted

If entries appear missing:

  • Check filter settings
  • Verify permissions to view all entries
  • Check system logs
  • Contact administrator

Audit Trail Questions ​

For specific audit needs:

  • Consult your compliance team
  • Review regulatory requirements
  • May need custom reporting
  • Contact MinuteView support for compliance documentation

Next Steps ​

Related topics:

Tentech