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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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FDA Warning Letter zu Datenintegritätsproblemen

Fragen der Datenintegrität stehen nach wie vor im Mittelpunkt bei FDA-Inspektionen. U. a. erhebliche Datenintegritätsprobleme bei Laborequipment waren Ursache für den Warning Letter an das dominikanische Unternehmen Laboratorio Magnachem International.

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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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Cloud Computing: Can an automated Deployment Chain replace an IQ?

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 17: Can an automated deployment chain replace an IQ? If so, what information must the deployment chain provide?

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Cloud Computing: Consequences of different service models for Qualification / Validation

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 16: What are the consequences of the different service models (IaaS / PaaS / SaaS / XaaS) for supplier management and the related qualification / validation?

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Cloud Computing: Validation of SaaS; who is accountable?

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 15: Special considerations for validation of SaaS; who is accountable?

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Cloud Computing: Assessment of Cloud Suppliers from an authority's point of view

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 14: What should the assessment of "cloud suppliers" include from an authority's point of view?

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Cloud Computing: Relevance of SOC / SOC2 reports

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 13: A cloud service providers refers to SOC reports when assessed, especially to the SOC2 report. Would this report be sufficient as concerns the requirements of the assessment and could it be used?

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GMP and critical Computerised Systems

During GMP inspections, inspectors should first look at critical (computerised) systems. Neither the EU GMP Guide nor Annex 11 or 15 give clear guidance on how to identify such critical systems. How can a system be established within the company to identify the criticality of computerised systems?

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