Cloud Compliance Assessments
Assessment of cloud and SaaS solutions for GxP compliance, data integrity, security and supplier assurance.
Overview
Cloud and SaaS adoption brings agility — and new compliance questions about control, data integrity, security and supplier assurance. The shared-responsibility model means some controls are the provider's and some are yours, and confusion about which is which is where risk hides. PharmExpert assesses cloud and SaaS solutions for GxP fitness, helping you adopt them confidently and compliantly.
We evaluate the provider's quality and security posture — certifications, development and change practices, and the assurance they can evidence — so you know what you can rely on and what you cannot. An unassessed provider cannot be the basis for a defensible validation.
We then map the shared-responsibility boundary explicitly, assess data-integrity controls across it, and define a risk-based validation approach: leveraging supplier assurance for infrastructure while validating the configured application for your intended use. This keeps validation proportionate without leaving gaps.
Finally we define the ongoing monitoring and periodic review that cloud demands, since the system you assessed can change beneath you. The result is cloud and SaaS adoption that is agile and compliant — with the controls clearly owned and evidenced.
What we do
- Cloud / SaaS supplier quality and security assessment
- Shared-responsibility and data-integrity evaluation
- GxP fitness and validation-approach review
- Infrastructure / IaaS-PaaS qualification considerations
- Ongoing monitoring and periodic-review design
- Risk-based control recommendations
Our process
- 1
Scope
Identify the cloud/SaaS systems and GxP risks.
- 2
Assess
Evaluate supplier posture and shared-responsibility controls.
- 3
Recommend
Define the controls and validation approach.
- 4
Monitor
Establish ongoing oversight and periodic review.
What you receive
- Cloud-compliance assessment report
- Shared-responsibility control matrix
- Validation-approach recommendation
- Ongoing-monitoring plan
Who needs this
Organizations moving GxP systems to the cloud, teams onboarding SaaS quality/regulatory tools, and companies needing supplier assurance for cloud.
Frequently asked questions
Ready to improve your compliance?
Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.
