GLP-Compliant Electronic Archives: Key Considerations for Labs

Key compliance and data integrity considerations for GLP digital archiving

In the landscape of regulated laboratory environments, Good Laboratory Practice (GLP) compliance is a cornerstone of scientific integrity and regulatory acceptance. As digitalization transforms research processes, many GLP laboratories are transitioning from physical to electronic long-term archives. While this shift offers substantial efficiency and accessibility benefits, it also introduces a new level of complexity and responsibility. A GLP-compliant electronic archive must maintain data integrity, security, traceability, and accessibility for decades. This article outlines the key regulatory, technical, and organizational considerations necessary for operating such an archive effectively and in full compliance.

1. Regulatory and Legal Compliance

Adherence to Regulatory Standards

An electronic long-term archive must meet strict regulatory requirements across different jurisdictions:

•    GLP Guidelines from authorities such as the OECD, FDA, EMA, and BfArM
•    21 CFR Part 11 (FDA) and Annex 11 (EU GMP) for electronic records and signatures
•    ISO 9001 for quality management systems and ISO/IEC 27001 for information security management

Data Retention Periods

GLP data must be archived for 10 to 15 years or longer, depending on the nature of the study and jurisdictional requirements. This imposes long-term responsibilities on data custodians to ensure continued access and legibility.

Audit Trails and Traceability

A compliant archive must capture a full, unbroken audit trail for every record:

•    Who accessed or modified data
•    When the changes occurred
•    What changes were made

All actions must be time-stamped and stored immutably.

Controlled Access and User Management

Access to the archive must be restricted to authorized personnel using:

•    Role-based access control (RBAC)
•    Strong authentication methods, such as two-factor authentication (2FA)
•    Clear administrative role segregation

2. Data Security and Integrity

Tamper-Proof Storage

Data integrity is paramount. Every file must be protected from unauthorized alterations. Technologies such as:

•    Digital Signatures
•    Cryptographic Checksums (Hashing)
•    Write Once, Read Many (WORM) Media

...ensure that data remains unchanged throughout its retention period.

Redundant and Secure Storage

To avoid data loss, laboratories must implement:

•    Geographically redundant backups (on-premise and cloud)
•    RAID storage systems for fault tolerance
•    Cloud services with long-term archival options (e.g., AWS Glacier, Azure Archive Storage)

Cybersecurity Measures

Robust defence strategies must be in place to mitigate cyber threats:

•    Firewalls and endpoint protection
•    Intrusion detection/prevention systems (IDS/IPS)
•    Routine vulnerability scans and penetration testing
•    Offline backup copies tested periodically for recovery readiness

3. Technical Requirements and Maintenance

Format and Media Longevity

Electronic archives must be future-proof. Recommended formats include:

•    PDF/A for documents
•    TIFF or JPEG 2000 for images
•    XML, CSV for structured data
•    WORM media for irreversible storage

Data must remain accessible despite technological changes. This may necessitate maintaining legacy software or emulation capabilities.

Regular Migration and System Updates

Archival systems must evolve with technology:

•    Scheduled migration of data to newer platforms
•    Validation after every migration to ensure data integrity
•    Avoiding data corruption or format incompatibility during transfer

Logging and Monitoring

All activities must be recorded and reviewed periodically:

•    Access logs, modification histories, download records
•    Monitoring of system health and integrity
•    Automated alerts for suspicious activity

4. Organizational Readiness and Documentation

Standard Operating Procedures (SOPs)

Clearly documented SOPs must govern every aspect of archival operations:

•    Data intake and classification
•    Access controls and data retrieval processes
•    Migration and decommissioning procedures

Staff Training and Responsibility Assignment

Personnel must be well-trained in both technical and compliance aspects of archiving. Laboratories must:

•    Assign an Archive Manager or designated person responsible
•    Conduct regular staff training and refresher courses
•    Document training records and access permissions

Validation and Audit Preparedness

System validation is mandatory to prove fitness for GLP use. This includes:

•    Installation Qualification (IQ)
•    Operational Qualification (OQ)
•    Performance Qualification (PQ)

In addition, laboratories must maintain records of:

•    Software and system version changes
•    Archive access and modification logs
•    Internal and external audit findings

Conclusion

Operating an electronic long-term archive in a GLP laboratory is not simply a matter of digitization—it is a rigorous process governed by legal, technical, and procedural controls. Laboratories must invest in robust systems, enforce strong access controls, uphold data integrity, and ensure their archival strategies are resilient to technological and regulatory change.
By addressing these considerations proactively, GLP laboratories can secure their digital assets, pass audits confidently, and support the long-term reliability and reproducibility of their scientific work.

References and Further Reading: