OECD Position Paper on Good Laboratory Practice and IT Security

This document provides a comprehensive framework of IT security measures designed to protect electronic Good Laboratory Practice (GLP) data. The key focus areas include:

1. Risk-Based Procedures:
   • Prioritize security measures based on assessed risks to ensure robust protection of GLP data.
2. Authentication and Access Control:
   • Implement strong authentication methods to restrict access to authorized personnel only.
   • Use secure remote access protocols to safeguard data during off-site operations.
3. Data Backup:
   • Establish regular data backup processes to prevent data loss and maintain integrity.
4. Physical Security:
   • Enforce stringent physical security measures to protect IT infrastructure and data storage facilities.
5. Security Incident Management:
   • Develop procedures to detect, respond to, and mitigate security incidents effectively.
6. Standard Operating Procedures (SOPs):
   • Define and implement SOPs to ensure consistent application of security protocols across operations.
7. Data Integrity Measures:
   • Regularly back up data and implement physical and procedural safeguards to prevent simultaneous data loss.
   • Provide clear guidelines for handling security incidents to uphold data integrity.

By addressing these key areas, the document aims to establish a robust IT security framework to ensure the confidentiality, integrity, and availability of GLP data.

Region: Global

Source: https://www.oecd.org/en/publications/reports.html?orderBy=mostRelevant&page=1