Consulting

Put AI into service without losing control of the regulated process

GxP Frame helps pharmaceutical, biotechnology, medical-device, CRO and CDMO teams govern, qualify and sustain AI-enabled work. Engagements can strengthen an existing implementation, establish a defensible path to production, qualify the people using the system or recover a program whose controls have not kept pace with adoption.

Start with intended use

The control strategy begins with the process, decision, data and potential impact—not the novelty of the technology.

Make evidence reviewable

Requirements, risks, tests, decisions, exceptions and changes should form a coherent record that another qualified person can evaluate.

Qualify the whole operating system

Technology, suppliers, procedures, data, people and oversight must work together. A technically capable model is only one component.

Consulting services

Support across the AI system lifecycle

Scope is tailored to the system's intended use, maturity, risk and regulated context. The work can address one urgent control gap or establish an end-to-end operating model.

Compliance oversight for existing implementations

An independent review of the intended use, regulated-process impact, current controls and retained evidence around an AI-enabled system already in use or approaching production.

Use-case, system and data-flow inventory
Control and evidence-gap assessment
SOP, change-control and escalation alignment
Human-review, exception and incident controls
Monitoring, periodic review and retirement planning

System qualification and validation

A risk-based qualification strategy tied to what the system is intended to do, the decisions it influences and the records or processes it can affect.

Intended-use and regulated-impact definition
Requirements, risk assessment and traceability
Supplier and platform assessment
Test strategy, acceptance criteria and evidence review
Release, change and validated-state maintenance controls

User qualification and authorization

Role-specific qualification that tests whether people can operate the system within approved boundaries—not merely whether they completed training.

Role, task and risk segmentation
Training-needs and prerequisite analysis
Scenario-based knowledge and performance assessment
Authorization, supervision and escalation rules
Remediation and periodic reassessment

AI governance and operating model

Practical governance that connects policy to ownership, evidence, decision rights and day-to-day execution across Quality, business, technology and data teams.

Governance charter and accountable-owner model
Use-case intake and risk-tiering workflow
Approval, prohibited-use and exception pathways
Lifecycle documentation and control standards
Management reporting and governance cadence

Vendor and platform assurance

Due diligence focused on whether a supplier's capabilities, controls and evidence are adequate for the proposed regulated use—not on generic feature claims.

Supplier-risk and responsibility mapping
Security, privacy and data-handling review coordination
Model, update and subcontractor transparency questions
Contractual-control and evidence requirements
Ongoing performance and supplier-change oversight

Inspection readiness and remediation

Focused support when AI-enabled work must be made reviewable, when controls have drifted, or when an audit, deviation or inspection exposes a weakness.

Evidence-room and inspection-narrative preparation
Control walkthroughs and record sampling
Finding triage and root-cause facilitation
CAPA and remediation-roadmap support
Effectiveness checks and sustainable handoff

Typical deliverables

Work products designed for decisions and handoff

Every engagement has a written scope and acceptance criteria. Depending on the need, the resulting package may include the following.

Current-state assessment and prioritized findings matrix
Use-case inventory, risk tiers and accountable-owner map
Intended-use statement and regulated-impact assessment
Qualification or validation plan with traceability
Supplier-assurance questions and evidence requirements
Governance procedures, decision rights and escalation pathways
Role-based curriculum, qualification criteria and authorization matrix
Monitoring, change-control and periodic-review plan
Remediation roadmap with owners, dependencies and stop/go thresholds
Management readout and controlled transfer to the operating team

Ways to engage

Focused intervention or sustained program support

The engagement model follows the decision the organization needs to make and the capability it needs to retain afterward.

Independent health check

A defined review of one system, use case or program, ending with prioritized findings, decision points and a practical remediation sequence.

Implementation workstream

Embedded support through design, supplier selection, qualification, controlled launch and transfer into routine operations.

Remediation and recovery

A time-bounded intervention to restore control, reconstruct evidence, resolve findings and establish a maintainable operating state.

Fractional quality and governance leadership

Ongoing senior support for organizations that need accountable program direction without adding a permanent specialist role immediately.

Experience behind the work

Regulated operations, quality systems and workforce qualification

Engagements are led by Brian J. Drapeau, founder and principal consultant of GxP Frame. His experience spans cell and gene therapy manufacturing, GxP training governance, inspection readiness, LMS and QMS implementation, role qualification and the practical governance of AI-assisted work. That operating background keeps recommendations tied to how regulated work is approved, performed, evidenced and sustained.

Review experience and credentials

Start with the decision

Discuss the system, risk and evidence you need to defend

The initial conversation identifies the use case, regulated context, current state, immediate decision and information restrictions before a scope is proposed.

Take the readiness assessment Contact Brian J. Drapeau