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'All computerised systems used for the generation, measurement or assessment of data intended for regulatory submission should be developed, validated, operated and maintained in ways which are compliant with the GLP Principles.'
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 10. GLP Consensus Document: The Application of the Principles of GLP to Computerized Systems, Environment Monograph No. 116, Paris, 1995.
Databases required for GLP work would include:
- User level security – user ID and password
- Activity logs
- Audit trails
- Termination of inactive sessions
In addition, if requested, we can provide full documentation of the system including design, source code and validation. We can also assist you in developing disaster recovery plans, writing SOPs and providing regular maintenance of the database.
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