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This pack focuses on ensuring that the Azure Infrastructure as a Service (IaaS) is configured properly and is qualified in accordance with applicable regulations and the clients Standard Operating Procedure(s) (SOPs).
Our qualification pack provides you with the framework to clearly document and test that your Azure IaaS is configured and controlled in a manner that can support regulated content.
All documents are based on GAMP5 standards. The document pack is based on the Microsoft Azure Qualification Guideline (download) and is composed of the following documents:
✔️ | Risk Assessment |
✔️ | Qualification Plan |
✔️ | Requirements Specification |
✔️ | System Description |
✔️ | Configuration Specification |
✔️ | IQ Protocols |
✔️ | OQ Protocols |
✔️ | Traceability Matrix |
✔️ | Qualification Summary Report |