"This is the best use of my time to remain current with what is going on in the industry."
With the increased focus on data integrity from regulators, the routine use of audit trail review as a tool is required. This team will explore and provide guidance on what is the recommended scope for review, provide definitions, determine ‘what’ data (and in what part of the data lifecycle) should be reviewed with an audit trail vs other data integrity controls and finally recommend ‘how’ an audit trail review should be conducted (frequency, visualizations, exception reports etc). A white paper will be released to eCF members in 1Q 2020 with the anticipation of releasing it to the public by 1Q 2021.
Japanese Translation: eSRA Handbook and Assessment Forms V2026
の日本語版2025.2JP1が2026年6月02日にリリースされました。
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Webinar "AI Validation"
As generative and agentic AI become part of pharmaceutical operations, how do we validate these systems in a practical way? If you are interested in this topic, join our webinar on June 24th 2026!