Cloud GxP validation

The problem in your words

The systems your quality processes depend on are moving to SaaS and IaaS. The provider runs the infrastructure, ships updates on their schedule, and holds evidence you used to generate yourself. The old qualification playbook assumes you control all of it. You do not, and pretending otherwise produces thick documents that prove little.

How I approach it

Cloud qualification is a shared-responsibility problem before it is a testing problem. We define who is accountable for what, between you and the provider, in a quality agreement that holds. Then supplier evidence is assessed and leveraged proportionate to risk, rather than duplicated. Validation effort concentrates on configuration and intended use, the parts you actually control, and on the change process for provider-driven updates.

This is the CSA risk decision applied to the cloud: impact, implementation method, risk rating, right-sized testing, with the supplier relationship treated as a control in its own right.

In the cloud you are not validating a box you own. You are assuring a relationship, a configuration, and a change process. Size the effort to that.

What you get

• A shared-responsibility model and quality agreement for each provider, including SaaS.
• A supplier-leverage approach that accepts provider evidence where it is justified.
• A change strategy for provider updates, with risk-based revalidation triggers.
• A migration approach proven at scale: in a comparable programme, 2,000+ servers moved in six months.