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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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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: 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 - 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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FDA criticises Equipment Qualification and Process Validation

In a current Warning Letter, the FDA has criticised inadequate device qualification and deficiencies in process and cleaning validation. What does the FDA require?

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FDA Warning Letter on Data Integrity Issues

Data Integrity issues continue to be the focus of FDA inspections. The Warning Letter to the Dominican company Laboratorio Magnachem International was caused by significant data integrity problems with laboratory equipment, among other things.

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Cloud Computing: Workaround for non-compliant PaaS

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 19: A non-(GXP-)qualified PAAS could change the versions of some of its generic microservices used by the application to be deployed as a GXP SAAS. Changing the versions of such generic microservices could be beyond the control of the SAAS provider. What would be required to make this scenario GXP-compliant?

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Cloud Computing: Validation performed by a CSP on its own - what is the Value?

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 18: What is the value of a "validation" performed by a CSP on its own for the services it provides?

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