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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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Annex 11 Draft - First Analysis

On 07 July 2025, the EU Commission published 3 drafts of the EU GMP Guidance Annex 11 “Computerised Systems”, the new Annex 22 “Artificial Intelligence” and Chapter 4 “Documentation”. Here is an initial analysis of the Annex 11 draft.

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Content of an Audit Trail / Must an Audit Trail be printable?

The requirements for an audit trail can now be found almost everywhere in the relevant pharmaceutical regulations. Six experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Questions 1 and 2: From an inspector's perspective, what are the minimum requirements for the content of an audit trail and must an audit trail be printable?

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USP: Chapter <1029> Good Documentation Guidelines and Data Integrity published for comment

The chapter "<1029> Good Documentation Guidelines and Data Integrity" has been published for comment on the website of the USP Pharmacopeial Forum since the beginning of July 2025. Comments and remarks on this draft, which is based on the previous version "<1029> Good Documentation Guidelines" from May 2018, can be submitted until September 30, 2025.

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Data Integrity & IT Compliance Group Developments January through April 2025

Find out what the ECA Data Integrity & IT Compliance Group was working on and accomplished in the first four months of 2025 - in the latest report.

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How does FDA train and guide its Inspectors?

The Investigations Operations Manual (IOM) is the primary operational reference for FDA investigators. Although primarily used internally by FDA staff, it is available publicly. The Manual has now been revised.

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FDA Warning Letter on missing Audit Trails and Raw Data Review

Among other things, the lack of verification of the electronic raw data and the audit trail led to a warning letter to a south african company. What did the FDA criticise?

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