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Cloud Computing: Authorities' Expectations od Cloud Service Providers?

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 29: Do the authorities accept that using cloud services entails a loss of control compared with on-premises operations?

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Cloud Computing: IT Infrastructure Qualification by a SAAS 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 28: Does a SaaS provider have to qualify the IT infrastructure used to provide services in the same way that a drug manufacturer or pharmaceutical company would have to?

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Cloud Computing: How can CSPs Achieve the Annex 11 Requirement of Qualified Infrastructure?

Financial and organisational advantages make a strong case for using cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions must be clearly understood. Nine experts from the pharmaceutical industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 27: How can CSPs achieve the Annex 11 requirement of qualified infrastructure, considering short product cycles? Which evidence / documentation is expected?

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FDA Warning Letter Due to Inadequate Controls over Data Deletion and Data Changes

Missing or inadequate controls to prevent the deletion of data and changes to records, among other issues, led to a Warning Letter. What's behind this?

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Setpoint Changes and Audit Trail Review

Setpoint changes are provided for in the batch record and are also verified there via dual verification (four-eyes principle). Can a risk-based approach be used to omit the audit trail review for this purpose in a process control system?

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Cloud Computing: Is it unnecessary for large CSPs to provide Evidence of their IT Infrastructure's Compliance?

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 26: Is it unnecessary for large CSPs to provide evidence of their IT infrastructure's qualification?

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Audit Trail: No Option to Add Comments

If the system does not provide any way to comment on changes, how can the issue be addressed?

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Equipment Qualification, Computer System Validation and Audit Trail in the Context of an FDA Warning Letter

Among other things, the failure to qualify a gas chromatograph – including the failure to validate the associated software – as well as the absence of an audit trail led to a Warning Letter issued to a Mexican company. What did the FDA criticise?

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Data Integrity & IT Compliance Group Developments January through April 2026

Find out what the ECA Data Integrity & IT Compliance Group was working on and accomplished in the first four months of 2026 - in the latest report.

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What is meant by Good Documentation Practice?

Documentation fulfils several key functions within the GMP environment and is an indispensable component of quality assurance. This raises the question: what exactly is meant by the term 'Good Documentation Practice'?

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