SaaS • Cloud • Hosted
SaaS & Cloud Validation
Cloud deployment changes who performs which controls — not whether the controls are needed. A validated SaaS system is the product of a clear shared-responsibility model backed by supplier assessment evidence.
Shared responsibility, explicitly documented
- Infrastructure qualification performed and evidenced by the provider
- Platform security, availability and backup responsibilities
- Configuration, access management and business process controls retained by the customer
- Data ownership, export rights and exit provisions
- Data location, transfer and retention commitments
- Notification obligations for changes and incidents
Continuous release and multi-tenant upgrades
Vendors release on their schedule, not yours. A workable approach defines a standing regression scope driven by risk, uses vendor release notes and sandbox windows, and documents post-release verification instead of pretending each release is a project.
Supplier assessment for cloud providers
Assessment should look at the provider's quality management system, software development lifecycle, testing evidence, change and incident management, security posture and third-party certifications — then record what is being leveraged and what the customer will independently verify.
Primary references
- FDA — Process Validation: General Principles and Practices
- FDA — Computer Software Assurance for Production and Quality System Software
- FDA — 21 CFR Part 11, Electronic Records; Electronic Signatures
- FDA — Data Integrity and Compliance With Drug CGMP
- FDA — General Principles of Software Validation
Information published on ValidationEngineering.com is educational and informational. It is not legal or regulatory advice and is not a guarantee of regulatory compliance or of any inspection outcome. Organizations remain responsible for their own quality decisions.
Next step
Deploying a GxP system in the cloud?
Tell us about the platform, the intended use and the timeline.