Cloud GxP validation
"Our estate is moving to cloud and the old playbook does not fit." Qualifying SaaS and IaaS the way you qualified on-premise systems wastes effort and still misses the real risks.
The provider assures
Infrastructure, platform availability and the updates they ship on their own schedule, backed by their own audited evidence.
You assure
Configuration, intended use and the change process for provider updates, with supplier oversight treated as a control in its own right.
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. Cloud programmes stall in the same places other transformations do; I wrote up those patterns in Why pharma transformations stall.
What I do here
- I draw the shared-responsibility line for each provider and write it into a quality agreement that holds.
- I assess supplier evidence and decide, with a documented rationale, how far it can be trusted.
- I design the qualification for your configuration, intended use and data flows, sized by the CSA risk decision.
- I set up the standing change process for provider updates, with risk-based revalidation triggers.
- I plan and govern the migration itself, at enterprise scale when the estate calls for it.
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 relied on in proportion 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. The full playbook is written up as the GxP Cloud Validation framework.
In the cloud you are assuring a relationship, a configuration, and a change process, rather than validating a box you own. Size the effort to that.
What you get
- A shared-responsibility model and quality agreement for each provider, including SaaS.
- A supplier-evidence approach that accepts provider testing where the risk justifies it.
- A change strategy for provider updates, with risk-based revalidation triggers.
- A qualification pattern each new cloud service lands into, instead of a fresh debate.
From a comparable cloud programme
Outcomes from a global pharmaceutical client, rewritten as an anonymised engagement. No employer or client is named.
Related services
Questions leaders ask
Can GxP systems run on SaaS or public cloud?
Yes, and regulated estates increasingly do. What regulators expect is that you understand the shared-responsibility split, hold a quality agreement with the provider, assure your own configuration and intended use, and control provider-driven change. Moving the infrastructure off premise does not move the accountability, which stays with you.
Do we need to audit AWS, Azure or Google Cloud?
Rarely in person. Hyperscale providers publish audited certifications such as ISO 27001 and SOC 2, and a documented assessment of that evidence, in proportion to your risk, is usually the defensible route. Your effort is better spent on the quality agreement, your configuration, and the exit and continuity arrangements.
How do we keep a validated state when the vendor pushes updates?
Through a standing change process instead of a project per release. Release notes are assessed against your intended use, regression testing is sized by risk, and the rationale is recorded. Providers with sandbox previews give you a head start; the discipline is having triggers that say when deeper revalidation is due.
Is cloud qualification different from on-premise qualification?
The intent is the same, confidence that the system does what it should, but the method shifts. You no longer install or own the stack, so installation evidence comes from the provider, and your qualification concentrates on configuration, intended use, data flows and supplier oversight. Copying the on-premise protocol wastes effort and misses the real risks.
Make the cloud move without a documentation explosion.
Book a conversation and bring your migration plan.
Request a conversation See the cloud validation framework