AWS / Azure / GCP / SaaS — leveraged, not re-proved.
CSA-native validation for cloud-hosted GxP systems: shared-responsibility mapping, provider-evidence leverage, tenant-configuration validation, and secure-by-default patterns.
Validating cloud and SaaS systems means establishing which controls are the provider's and which remain yours, then validating your configuration and your use of the service. The provider's evidence can be leveraged where you have assessed them. A SaaS application may legitimately have no Installation Qualification, and that is a determined scope rather than a missing stage.
Outcomes you can expect
- Shared-responsibility matrix
- Provider evidence pack
- Tenant configuration validation
Cloud & SaaS Validation is delivered by our validation & compliance services practice. Where it saves time, the team uses our products: GxP Copilot for validation lifecycle work and TraceDraft for clinical documentation.
Explore related capabilities: Computer System Validation (CSV), Computer Software Assurance (CSA), AI Validation Services (Annex 22), FDA 21 CFR Part 11 Compliance.
The Shared Responsibility Model and GxP Compliance
Cloud-hosted GxP systems operate under a shared responsibility model: the cloud provider is responsible for the security and availability of the infrastructure; the regulated organisation is responsible for the configuration of the application layer, the data it stores, and the compliance of the processes it runs. This division of responsibility is well-established in IT security, but its implications for GxP validation are less widely understood. The organisation cannot outsource its validation obligation to the cloud provider — but it can leverage the provider's ISO 27001, SOC 2, and FedRAMP documentation to address infrastructure-level qualification requirements without re-proving them.
A cloud-validation engagement begins with a shared-responsibility matrix: a systematic mapping of every Annex 11 and 21 CFR Part 11 requirement against the layer of the stack responsible for meeting it — cloud provider, SaaS vendor, or regulated organisation. This matrix drives the scoping decision for the validation package: what the cloud provider's compliance documentation covers (and can therefore be leveraged), what the SaaS vendor's validation package covers, and what the regulated organisation must validate itself.
Tenant Configuration Validation: Where Compliance Actually Lives
For most cloud-hosted GxP SaaS systems, the regulated organisation's primary validation obligation is the tenant configuration — the specific settings applied to their instance of the application: access controls, electronic signature configuration, audit trail settings, workflow configuration, integration endpoints, and data retention policies. These settings are what differentiate a compliant GxP deployment from a non-compliant one, and they are under the regulated organisation's direct control.
Tenant configuration validation follows a GAMP Category 4 approach: the vendor's standard functionality is accepted based on vendor testing; the organisation's configuration is specified, documented, and verified through OQ test scripts targeted at configuration-dependent behaviour. Our cloud validation practice has validated SaaS GxP applications on AWS, Azure, and GCP including Veeva Vault, MasterControl, TrackWise, and Benchling, with reusable shared-responsibility matrices for each major cloud provider.
Sources
Primary documents referred to on this page, from their official publishers.
- 21 CFR Part 11: Electronic Records; Electronic Signatures · eCFR (US)
- EU GMP Annex 11: Computerised Systems (current version) · European Commission
See it on your own system.
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