AI GOVERNANCE
Our approach to AI governance.
AI GOVERNANCE
VERHEIM’S APPROACH TO AI GOVERNANCE
Bringing AI into GxP work raises practical questions. Your quality, IT and security teams need to understand the setup, the boundaries and their responsibilities.
Verheim’s approach makes the responsibilities clear: how SAGA supports the work and what remains with your designated people.
SAGA prepares deliverables. It does not write to your document management system or quality management system, and it does not sign.
Formal review, approval and controlled records remain in your systems, under your procedures, with your designated people.
The starting point is the material needed for the task.
For Deviations and CAPA, your team supplies files such as event records, procedures, investigation results and relevant earlier cases. These workflows do not require a connection to your source systems.
Where a source connection is agreed for another workflow, its setup and permissions are scoped for the engagement.
Verheim states the configurations each SAGA module is built and checked for.
A change to a different model requires re-checking against the workflow requirements. The supported setup and the implications of changing it are part of the conversation before implementation.
Your designated people assess the professional content, make the decisions and approve under your procedures.
Verheim verifies the defined functions and workflows. That verification is not computerised-system validation for your intended use; that responsibility remains within your quality system.
Have questions about data handling, security or your intended setup? Bring your IT, security and quality colleagues into the conversation so we can address the specific requirements together.
LET’S TALK
Tell us what your team needs to produce and what you need to understand before introducing AI. We can walk through a relevant SAGA workflow and discuss the setup, review and responsibilities around it.