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Content Review of the Audit Trail Review

Which individuals in which roles are responsible for reviewing the audit trail? What role does QA play?

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Executing the Audit Trail Review

How and by whom is the audit trail review carried out? Is a four-eyes principle (always) necessary?

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Data Integrity and the ICH Q7 Guidance - Part II

It is important to understand that (quality) risk management is essential to the implementation and maintenance of Data Integrity concepts. In order to control the risks they need to be categorized. Such a categorization must be simple and easy to be applied fast, consistently and reliably.

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Risk-based Determination of the Scope and Frequency of Audit Trail Reviews

The scope and frequency of audit trail reviews should be determined on a risk basis. Is there a regulatory basis for this?

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Data Integrity and the ICH Q7 Guidance - Part I

The question we want to explore is whether Data Integrity is a completely new approach or just a different perspective on already existing GMP requirements as those arising from ICH Q7.

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Responsibilities for the Audit Trail (Review)

There should be an SOP for the audit trail review that also defines responsibilities. Who creates such an SOP and who is the process owner for the audit trail review?

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Dealing with Systems without Audit Trail Functionality

The requirements for an audit trail are formulated even more comprehensively in the current draft of the revised Annex 11. But how should systems without an audit trail be handled, and do legacy systems need to be retrofitted with audit trail functionality?

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Audit Trail Review by the QP / Dealing with a Lack of Justification

What is the role of the QP in the audit trail review in connection with batch release, and does a lack of justification in the audit trail automatically lead to a complaint in an audit? How would an inspector respond to these questions?

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Events in an Audit Trail and Determination of GMP-Relevant Data in the Audit Trail

Changes and deletions of GMP-relevant data must be logged in the audit trail. Which events must be recorded in the audit trail and who determines which data is relevant for the audit trail?

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How to Deal with Audit Trails in Preconfigured Equipment?

In preconfigured equipment, you cannot set or configure the audit trail. How do you deal with this?

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