Essential Checklist for eTMF Archiving

1.1 Define and Objectives 

• Establish Archive Purpose and Scopes 

  • Regulatory Compliance:  
    • Ensure documentation is archived to meet ICH-GCP, EMA, FDA 21 CFR Part 11 
    • Other local regulations 
    • Ensure documentation follows ALCOA+ principles 
  • Long-Term Data Retention: Archiving records for the legally required period, often 25+ years 
  • Inspection Readiness: Guarantee that archived documents are structured and accessible to facilitate regulatory inspections
  • Data Preservation: Protect against technological obsolescence by maintaining accessible data formats and metadata 
  • Data Security and Integrity: Maintain secure and tamper-proof records for future audits or reviews
    
     

1.2 Establish a Detailed Archival Plan 

• Regulatory Requirements: 

  • ICH GCP E6(R2): Specifies the retention of records in a way that ensures completeness and accessibility 
  • FDA 21 CFR Part 11: Governs the security and electronic signatures needed for eTMF systems
  • EMA Guidelines: Emphasizes traceability, accessibility, and audit trails for TMF documents

• Clearly Laid out SOPs: 

  • TMF Structure SOP: Defining how documents are indexed and organized according to the TMF Reference Model 
  • Archival Process SOP: Steps for preparing documents, conducting quality checks, and transferring documents into the archival system
  • Access Control SOP: Procedures for managing permissions and maintaining data security during and after archiving
  • Inspection Readiness SOP: Processes ensuring that the archived eTMF is always ready for audits and inspections 
    • Ensuring your data retention policies are aligned with regulatory requirements
    • Ensure your audit trail is accessible, and legible in case of inspection 

3.1 Select a Validated eTMF Archival System 

• System Features: 
  • Document Locking: Ensures documents are uneditable once archived 
  • Audit Trails: Maintain logs for each document action (upload, modification, access) 
  • Encryption: Encrypt data at rest and in transit to protect against unauthorized access 
  • Validation Checks: 
    • Verify the system is compliant with 21 CFR Part 11 Requirements, including secure electronic signatures 
    • Ensure the system meets other validation standards, such as HITRUST and ISO 272001
  • Formatting Requirements: 
    • Ensure documents meet formatting requirements such as PDF/A and CSV 
    • Ensure archival solution can guarantee long-term legibility of digital content and reserve all common file formats 
  • Inspector Access: 
    • Ensure archival system can provide inspectors access to the archive in the original eTMF presentation within a reasonable span of time 
    • The content of the clinical trial master file shall be archived in a way that ensures that it is really available and accessible, upon request, to the competent authorities

5.1 Document and Archival Process 

• Process Documentation: 
  • Include details like the person responsible, timestamps, and approval logs for each archival activity
• Record any deviations from the SOP and corrective actions taken
  
   

5.2 Secure Storage and Retention

• Data Retention Strategy:
  • Ensure compliance with minimum storage periods (e.g., 25 years as per EMA guidance)
  • Vendor Assessment: If using external archives, verify vendor compliance and quality assurance processes