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APIC: Update of Data Integrity FAQs

In January 2025, the Task Force "Data Integrity" of the Quality Group of APIC, a sector group of the European Chemical Industry Council (CEFIC), published version 2 of the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. Updated and new questions and answers can be found in the "Password management" and "Access management" sections.

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First GDP Non-Compliance Report of 2025: Data Integrity Issues at Hungarian Wholesaler

The competent authority of Hungary has issued a new GDP Non-Compliance Report in the EudraGMDP database. The report mentions two critical observations: data integrity problems and unauthorized personnel performing critical decisions regarding medicinal products.

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Cloud Computing: Documents for a smooth migration to the cloud

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 25: What documents are required for the Pharmaceutical Entrepreneur to plan for a smooth migration to the cloud?

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Cloud Computing: Open or Closed System according to 21 CFR Part 11?

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 24: If the pharmaceutical user has data in the cloud, what type of system is it? Is this an open or closed system according to 21 CFR Part 11?

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Cloud Computing: Validation documents for a SaaS application

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 23: What validation documents are required for a SaaS application? Who provides which documents?

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Cloud Computing: What happens if the CSP does not allow audits?

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 22: The information on the Quality System and on audits concerning suppliers or developers of software and systems used should be made available to inspectors on request. What happens if the CSP does not allow audits? What alternatives to an audit would be accepted?

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Cloud Computing: Are (GMP) Supervisory Authorities allowed to inspect CSP?

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 21: Are (GMP) supervisory authorities allowed to inspect CSP? If not, is this planned for the future?

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Cloud Computing - Content of a SLA/Contract with a XaaS Provider

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 20: What should be the content of a SLA / contract with a XaaS provider?

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US FDA Warning Letter: Lab Data Integrity issues

In September 2024, the U.S. FDA issued a Warning Letter to the Indian company "MMC Healthcare Ltd." after having inspected its site in March 2024. According to the Warning Letter, the firm failed to have "appropriate controls to assure the integrity of electronic test data, such as an audit trail and defined user access levels".

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EDQM publishes New Chapter "Quality of Data" for Comments

The draft of the new chapter '5.38. QUALITY OF DATA' has been published on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare) in the Pharmeuropa section and can be commented on until 31 December 2024, along with several other new drafts.

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