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Computerised Systems GMP Guidelines

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General Principles: Computerised systems are software and hardware components fulfilling specific functionalities
Risk management should be applied throughout system lifecycle
All personnel should have appropriate qualifications and defined responsibilities
Validation and Documentation: Validation documentation should cover life cycle steps and include change control records
User requirements should be traceable throughout system life-cycle
System inventory and detailed descriptions should be available for critical systems
Data Management: Electronic systems should include built-in checks for data accuracy
Data should be secured physically and electronically with regular backups
Audit trails should record all GMP-relevant changes and deletions
Security and Incident Management: Access controls should restrict system access to authorised persons
Incidents should be reported and assessed with root cause identification
Electronic signatures should have same impact as handwritten ones
Business Continuity: Provisions should ensure business continuity in case of system breakdown
Alternative arrangements should be documented and tested
Data archiving should be checked for accessibility and integrity