Controlled process
Versioned procedures, defined steps and permissions give teams a consistent way to execute the work.
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Regulatory controls
Make AI-assisted work ready for regulatory review
Flownium connects each AI-assisted step to an approved workflow, an attributable audit trail and the people responsible for the decision.
Attributable history
The record links sources, timestamps, changes and human actions across the workflow.
Reviewable package
Evidence, workflow version, decisions and approvals are retained together for quality review.
The expectations this supports
21 CFR Part 11
Electronic-record controls such as validation, audit trails, access checks and electronic signatures apply where the rule is in scope.
EU Annex 11
Computerised-system expectations include validation, audit trails, security and record availability.
Applicable requirements depend on the record and deployment. Flownium provides supporting controls; the customer remains responsible for validation, procedures and the final compliance assessment.