Everyone who has read recent drug GMP warning letters and forms 483 know that the issue of data integrity remains a high priority among regulatory investigators. And among enforcement actions, the words ‘audit trails’ are mentioned frequently, and have been for over ten years. I will address, at a high level, the purpose and value of audit trails, features that their configuration should ensure, and how they should be managed after they are enabled. Appendix 1 provides a list of some features that should be considered in system configuration to ensure that audit trails are adequate and meet regulators expectations. Appendix 2 provides a sample of eight deficiencies identified in warning letters that mention ‘audit trails’.
CONCLUSION: Validated computer systems with enabled audit trails are necessary, but not sufficient, to meet…READ MORE
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