Validating SaaS Systems You Do Not Control

The supplier assessment is the foundation

When infrastructure qualification, development lifecycle and release testing are performed by the supplier, your assurance case rests on evidence that those activities are real and adequate. That evidence has to be assessed, retained and refreshed — not assumed from a certification logo.

Continuous release requires a standing process

• Contractual notification of releases and their content
• Impact triage against your configured, GxP-relevant functionality
• A maintained regression set focused on your critical workflows
• Sandbox or pre-production verification where available
• Documented post-release verification for high-impact changes

Configuration is your responsibility, always

Roles, privileges, workflows, calculations, electronic signature settings and audit trail options are yours. This is where most cloud validation effort belongs, and where most findings originate.

Data portability and exit

Retention obligations outlast most vendor relationships. Confirm early that you can export complete records — including audit trails and metadata — in a readable form, and that the export has been tested rather than promised.