The "Human-on-the-Loop" Governance Sprint 2–4 weeks
You can’t validate the model yet, but you must validate the interaction (Principle 8)
Context of Use Statement (Aligned to Principle 1)
Human-AI Interaction Rubric (Aligned to Principle 8)
Failure Mode Taxonomy (What happens when the agent hallucinates?)
Best For: Teams building "Agentic" workflows who need to prove they are in control before scaling.
Agentic Evidence Generation (Full Validation) 6–10 weeks
Move from 'Software Validation' to 'Evidence Integrity' (Principle 6). If the decision isn't traceable, it’s not evidence.
Decision Lineage Map (Traceability per Principle 6)
Model Credibility Plan (The new "Validation Plan")
Audit-Ready Evidence Pack
Best For: Clinical Ops, Safety, and Regulatory teams who need to defend the output to an auditor.
Lifecycle Drift Assurance (Principle 9 Service)
"Principle 9 mandates 'scheduled monitoring' for data drift. This is your regulatory insurance policy.
Quarterly Principle 9 Report (Documented proof of drift monitoring)
Change Control Impact Assessment (When they prompt-engineer a new version)
Best For: Organizations with LLMs in production
The GxP Bridge to AI Quality
Format: 5 Virtual Sessions (90 Mins Each) + Async Templates
Target Audience: Traditional QA/CSV Leads & Data Integrity Officers
The "Red Team" Inspection
A "Vulnerability Scorecard" showing exactly where the human-on-the-loop failed during a simulated hallucination.
Best for: Regulatory affairs teams preparing submissions; Quality/CSV/CSA teams doing inspection readiness; Clinical ops/CMC teams wanting a pre-inspection gap scan before QA review
The Principle 8 Gap Screen
In 20 minutes, I’ll tell you if your current human oversight strategy would pass a Principle 8 audit
No pitch. No pressure. Just clarity on whether this is the right path.