Validating software fda

27-Sep-2017 03:45

Properly capturing validation documentation is key for deploying cloud-based solutions and should be documented in accordance with the company’s internal SOPs.If an auditor reviews a company’s software environment, the company must be able to demonstrate how the software was validated per its internal SOPs.However, the nagging challenge of validation of these systems is still widely misunderstood among life sciences professionals.

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Basics of cloud computing On the most basic level, cloud computing refers to using “virtualized servers” distributed over the Internet to store, access and manage data instead of on physical servers inside corporate network infrastructures.The common deployment patterns of cloud computing are single and multi-tenant.The single-tenant cloud is an architecture in which a single instance of a software solution and supporting infrastructure is “hosted” on servers in the cloud for one customer.This flies in the face of trends in the cloud computing delivery model, which favors frequent releases of new features across all customers at a pace controlled by the software vendor.

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However, the benefits of cloud-based deployments have ushered in a new class of Quality Management Systems (QMS) that have transitioned successfully to the cloud.This is a similar model to on-premise in that it is one singular system with software installed and the company is the only one accessing it.