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Validating AI in a GxP Environment: Governance, CSA and Human Oversight

Validating AI in a GxP environment means establishing credibility per context of use - not running legacy CSV scripts against a black box. Every agentic workflow gets a defined level of autonomy, a risk-scaled evidence package, and a named accountable owner. It's not guidance or policy - it's system configuration, enforced by the quality management system and recorded in the audit trail on every single action.

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VALIDATION

Don't take our word for it.

Take the regulators'.

Every agentic workflow is assessed using the same risk-based credibility framework
regulators have established for AI supporting regulatory decision-making.

Credibility is not something a system earns once. It is established for each specific context of use, with the level of evidence determined by two factors: how much the model's output influences the decision, and the consequence of getting that decision wrong.

The Credibility Assessment Framework

Seven steps:

Define the question of interest

State the exact question the model must help answer - not what the technology does, but what decision it supports.

Define the context of use

Set out the precise role and scope of the model, including what other evidence and human judgement sit alongside it.

Assess the model risk

Evaluate the influence of the model's output and the consequence of an incorrect decision. Together, these determine the level of evidence required.

Plan how credibility will be established

Define in advance what evidence is needed, proportionate to the risk identified in step three.

Execute the plan

Generate the evidence: performance against reference datasets, behaviour at the boundaries, and the conditions where performance degrades.

Document results and deviations

Record what was found, where reality differed from expectations, and what actions were taken.

Determine adequacy for the context of use

Decide whether the evidence supports using the model for that specific purpose. Credible for one context of use does not automatically mean credible for another.

AI in Pharmacovigilance

Three Modes of Human Oversight

Explore how agentic AI changes each core pharmacovigilance workflow and what regulators expect of it.

In The Loop:

approve before it happens..

The agent assembles the case, reasons over it, and presents a decision-ready package - its evidence and its uncertainty made explicit.
A qualified human authorises. The agent cannot proceed without that signature.

Applied to:

Causality assessment sign-off
Expedited report submission
Labelling and RSI decisions
Signal validation outcomes

On The Loop:

supervise while it happens.

High-volume, well-bounded work runs autonomously and continuously. Humans don't touch every case: they watch the quality signal, review sampled output, and intervene on the exceptions the system itself flags as outside tolerance.

Applied to:

Case intake and triage
Duplicate detection
MedDRA coding and narrative drafting
Literature and translation screening

In Command:

own the system itself.

Humans define what the agents are allowed to be. Scope, thresholds, escalation rules, competence boundaries. Quality standards are set by named, accountable people and any workflow can be halted, narrowed, or re-qualified at any moment.

Held by:

QPPV and deputy
Quality management system owner
Agent authorisation and scope board
Named process owners

These modes operationalise the humans-first implementation models described in CIOMS Working Group XIV methodology.

QUALITY

Unified Quality Management

One Rulebook. No exceptions for AI.

Most AI in drug safety sits outside the quality system, treated as a tool that must be separately validated. iVigee's agents operate inside it - governed by the same rules, the same qualification logic, and the same deviation processes as the human professionals they work alongside. The result: quality improvements that are built into the system, fully traceable, and auditable - not just claimed.

Every role. One standard.

A pharmacovigilance department is not one job. The GPPC framework defines 75 distinct roles, each requiring a specific level of knowledge, skills, and professional competence. iVigee provides agentic capability across all 75 roles. Each agent is qualified for the role it performs and held to the same competency standard as the human professionals it works alongside. Because quality cannot depend on whether the work is performed by a person or an agent. The standard must apply equally to both.

Leadership Roles

Accountable for pharmacovigilance, strategy and the overall PV system.

Managerial Roles

Manage PV functions, teams, projects and vendor relationships

Scientific Roles

Case assessment, signal, risk, data science and medical writing

Technical Roles

Operate and administer PV systems, data entry, coding, and quality processes

FAQ

Through risk-based credibility assessment per context of use: define the question and context, assess model influence and decision consequence, scale the evidence to that risk, execute, document deviations, and judge adequacy - the same logic as FDA draft guidance and CSA principles.

An oversight mode where high-volume work runs autonomously while qualified humans monitor quality signals, review sampled output and intervene on flagged exceptions — one of the humans-first models (HIC, HITL, HOTL) described by CIOMS WG XIV.

No. Credible for one context of use does not automatically mean credible for another — each workflow carries its own assessment, and any workflow can be halted, narrowed or re-qualified at any moment.

Named people, always: the QPPV and deputy, the QMS owner and named process owners. Every action - human or agent - is captured in a single end-to-end audit trail.

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