14.02.24

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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07.02.24

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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24.01.24

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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17.01.24

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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10.01.24

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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13.12.23

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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29.11.23

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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17.05.23

Cloud Computing: Is a check list for the assessment of a Cloud Service Provider sufficient?

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 12: Will it be sufficient to send a check list for the assessment of the CSP - for instance Amazon and Microsoft?

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10.05.23

Cloud Computing: Audit / Remote audit of a Cloud Service 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 11: How many days must be planned for the audit of a CSP? Is it also possible to carry out a remote audit?

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03.05.23

Cloud Computing: Which Persons should participate in the Audit of a CSP and which Topics should be addressed?

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 10: Which persons (functions) should participate in the audit of a CSP and which topics should (must) be addressed?

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