Back to the Basics of CSV Ep.2: Data Integrity and Cloud-Based Systems: Leveraging a Mature Quality Management System

As organizations move to cloud-hosted and SaaS platforms, traditional validation boundaries blur.
This session examines how to maintain data integrity, traceability, and oversight in cloud-based environments, using the QMS as a control framework rather than a constraint.

Participants will:
Apply data integrity (ALCOA+) principles to cloud environments.
Understand shared-responsibility models between vendor and regulated company.
Leverage a mature QMS for effective supplier and service-provider oversight.
Implement risk-based validation and assurance strategies for cloud systems.
Balance innovation, agility, and compliance through QMS governance.

Key Takeaways
GxP responsibility cannot be outsourced - it must be managed through your QMS.
A robust QMS provides the governance backbone for compliant cloud adoption.
Leveraging supplier documentation is efficient when justified by risk and verified under the QMS.