OECD The Application of GLP Principles to Computerised Systems DRAFT, 9/14

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In late 2014, the Organisation for Economic Co-operation and Development (OECD) published The Application of GLP Principles to Computerised Systems to establish standards for laboratory computer systems used in clinical studies destined for regulatory submissions. Once approved by consensus, this document will replace a similarly named document from 1995.

The document addresses laboratory computer system:

• Risk-based validation methodology and deliverables

• Responsibilities of management, QA, and other personnel

• Software suppliers and service providers, including developers, hosting services, validation services

• Commercial off-the-shelf system products

• System inventory

• Training and support

• Business continuity and disaster recovery

• Data integrity, retention, back-ups, and archival

• Audit trails

• Electronic signatures

• Periodic evaluation

• Physical and logical security

• Change and configuration management

• Incident management

• System documentation

• SOPs for system development, validation, security, archival, operation, change control, maintenance

This document refers to PIC/S PI 11 “Good Practices for Computerised Systems in Regulated GxP Environments” for additional guidance on validation, change management, and configuration management.