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Agentic AI Governance for Regulated Operations

QikSolve provides a governance framework for generative AI and agentic workflows in GMP and GMP-adjacent organisations, with an initial focus on Microsoft 365 Copilot usage. The framework is designed to support practical AI adoption while preserving human accountability for GMP-relevant decisions.

Why Agentic AI Governance Matters

Many regulated organisations adopt generative AI tools before formal governance is in place. This creates gaps in accountability, traceability, and change control, and increases exposure to compliance findings. A structured governance model closes these gaps with a repeatable, risk-based operating approach.

What This Service Includes

  • Risk-tiered use-case model, classifying AI use by regulated impact and control depth.
  • Microsoft 365 Copilot control baseline, defining approved, restricted, and prohibited usage patterns.
  • Human review and approval gates for GMP-relevant AI-assisted outputs.
  • Audit evidence model, defining minimum evidence fields for AI-assisted work.
  • Change control framework for prompts and AI configuration.
  • Role-based training for users, reviewers, and governance owners.

Benefits

  • Human oversight retained for all GMP-relevant AI-assisted decisions.
  • Evidence posture designed to support audit and inspection readiness.
  • Consistent, role-owned controls in place of ad hoc AI usage.
  • A proportionate, risk-based path to safer AI adoption.

This framework has been applied in a pilot engagement with a regulated GMP manufacturer, supporting a controlled transition from unmanaged consumer AI tools to a governed Microsoft 365 Copilot rollout.

Contact QikSolve today to learn more about Agentic AI Governance for Microsoft 365.