If you are an SMB Lifescience company, then you need to ask the question: Is my IT Infrastructure / Apps Data Integrity Compliant?
As companies – especially those in the life sciences space – begin moving their workloads to the public cloud, they’re faced with the challenge of maintaining GxP compliance for a constantly changing cloud environment.
To remain competitive in today’s climate, life sciences companies need to be able to continuously research and develop new, differentiated features and products. That’s why they’re increasingly moving their IT infrastructure from on-prem data centers to the cloud.
In April 2016, the FDA put out its draft guidance on Data Integrity and Compliance With cGMP, which helped to clarify the FDA’s stance on data integrity.
The initial qualification of IT infrastructure is challenging, but even more effort is required to maintain the qualified state (QS). By using the model presented here, you can ensure the QS integrity of your AWS solution to avoid any tedious requalification efforts.
Many life sciences companies are interested in moving their GxP workloads to the public cloud but aren’t sure about the toolsets they’ll need to qualify the various Infrastructure-as-a-Service (IaaS) and Platform-as-a-Service (PaaS) solutions that are constantly changing.
Most Azure users agree that Azure Infrastructure-as-a-Service (IaaS) can be qualified, but there are still questions around whether Azure Platform-as-a-Service (PaaS) – which includes serverless architectures – can be qualified as well.
