Cloud validation is the process of establishing and maintaining documented confidence that a cloud-based system is fit for its intended GxP use. SaaS validation applies the same principle specifically to software delivered as a service.
Cloud services operate under a shared-responsibility model. The allocation of responsibility depends on the service model, architecture, contract, and configured solution. Suppliers may control significant portions of the infrastructure, platform, software, and release process, while the regulated company remains accountable for the suitability of the system for its intended regulated use.
Supplier evidence may include development and testing documentation, service-control reports, security assessments, certifications, release information, and product documentation. Each item should be evaluated for relevance, reliability, and sufficiency. Supplier evidence alone does not establish that the customer’s specific configured implementation is fit for the customer’s intended GxP use.
Validation should therefore address the customer’s intended use, configuration, workflows, data, interfaces, access model, and applicable controls, while leveraging suitable supplier evidence to avoid unnecessary duplication.
Cloud validation also requires ongoing validated-state maintenance because supplier releases, configuration changes, integrations, security changes, and changes in intended use may affect existing assurance evidence. Automation can support change detection, impact assessment, traceability, and document maintenance when appropriately governed and reviewed.
Frequently Asked Questions
Can a SaaS vendor validate the system for us?
A supplier can provide evidence and may perform validation services, but the regulated company retains accountability for concluding that its specific implementation is fit for its intended GxP use.
How is cloud validation different from validating on-premises systems?
Cloud validation places greater reliance on supplier oversight, formal allocation of responsibilities, and evaluation of evidence for layers operated by the supplier. Customer assurance focuses on intended use, configuration, data, interfaces, controls, and the parts of the service under customer responsibility.
How do we handle vendor releases in a validated cloud system?
Manage applicable releases through change management. Identify what changed, assess potential effects on GxP functions and existing evidence, perform additional assurance where justified, and document the conclusion.
Is it acceptable to run GxP processes on cloud platforms?
Yes. Cloud platforms can support GxP processes when appropriate supplier oversight, assurance, data-integrity controls, security, change management, and ongoing governance are established for the intended use.