GCP: What’s needed from a Digital Archiving solution?

It is not that easy to have proper information with regard to the requirements for digital archiving and preservation solutions in pharmaceuticals. That’s why we’ve created this overview with all the information that we could find from different sources.

So, here it is: A comprehensive overview of all the functional and technical requirements for digital preservation and archiving under Good Clinical Practice (GCP) (GxP), integrating best practices from both GCP guidelines and industry sources.

Functional Requirements

1. Data Integrity and Accessibility:

• • Clinical trial data must adhere to ALCOA++ principles: it must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available, and traceable. These standards ensure data integrity and accessibility throughout its lifecycle.
  • Essential documents should be archived in a manner that guarantees their availability and retrievability over the full retention period, which is typically 25 years after trial completion​.
    

2. Retention and Legal Compliance:

• • Retention schedules must be established to define how long records should be preserved, often a minimum of 5 to 25 years, based on legal and regulatory requirements, including marketing authorizations.
  • Legal holds may require that certain records be preserved beyond standard timelines. Documentation supporting these requirements ensures all relevant data remains accessible during audits or investigations​.

3. Disaster Recovery and Business Continuity:

• • A disaster recovery plan must be in place. This plan should outline access points, recovery resources, and emergency contacts.
  • Business continuity measures should address risks unrelated to disasters, such as equipment or personnel issues, to ensure that archives remain functional and accessible without interruption.

4. Control of Access:

• • Access to the archive should be limited to authorized personnel, with role-based permissions. A formal process for handling access, retrieval, transfer, and destruction of archived materials is essential to maintaining traceability​.
  • Archives should have procedures for removing or transferring control when an individual or organization exits their role or ceases operations, including continuity plans for archive custody.
    

5. Audit Trails:

• • Digital systems must have audit trails that capture all modifications, including time stamps and user identification for each entry. These trails ensure full traceability and accountability across the data lifecycle​.

Technical Requirements

1. Validation of Digital Systems:

1. • All computerized systems used for archiving should undergo validation to confirm their accuracy, reliability, and regulatory compliance. This includes the capacity to prevent unauthorized data changes, support audit trails, and reliably reproduce original records​.
   • Certification processes, including digital copies that can replace original documents, must meet standards to ensure they reflect all critical data and metadata of the originals​.

2. Archive Storage Conditions:

1. • Digital archives should be designed to protect materials from environmental risks (e.g., fire, flooding, pest damage). Storage conditions must stabilize temperature, humidity, and other factors to prevent material degradation.
   • Security protocols to prevent unauthorized access are required.

3. Backup and Disaster Recovery:

1. • Regular backups are necessary to maintain data integrity. Systems should enable disaster recovery to protect data against loss from system failures or other unforeseen events. Backup and restore functions should be periodically tested to verify data integrity.

4. Security and Access Control:

1. • Security protocols should include role-based access, secure passwords, and user authentication to prevent unauthorized access to archived data. Remote access, when required, should be limited to non-identifiable data.
   • Documents are stored in read-only formats when appropriate to prevent unintended modifications​.

5. Data Migration and Media Longevity:

1. • The archive should have provisions for data migration and regular assessments of media longevity. This is essential to ensure data readability as technology evolves and storage media age.
   • Media used to store data should be maintained under appropriate conditions, and any transfer or migration should be validated to ensure data consistency and preservation of metadata​.

6. Compliance with Regulatory Standards:

• • Archives must align with regulatory standards, such as 21 CFR Part 11 (for electronic records and signatures) and EMA guidelines, ensuring that electronic records are verifiable, reliable, and compliant with applicable laws.

These comprehensive functional and technical requirements ensure that digital archives meet GCP guidelines, maintaining clinical trial data integrity, accessibility, and long-term preservation to support regulatory compliance and audit readiness.