OECD The Application of the Principles of GLP to Computerised Systems, 2/95

$0.00

In 1995, the Organisation for Economic Co-operation and Development (OECD) published The Application of the Principles of GLP to Computerised Systems to establish standards for laboratory computer systems used in clinical studies destined for regulatory submissions.

The document addresses laboratory computer system:

• Validation

• Responsibilities of management, QA, and other personnel

• Training and support

• Hardware, software, and communication equipment

• Maintenance and disaster recovery

• Data retention, back-ups, and archival

• Audit trails

• Physical and logical security

• Change control

• System documentation

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