1
Govern
Define intended use, decision rights, risk class, SOP impact, and who owns the final judgment.
Business outcome
Faster approval to pilot without compliance ambiguity.
Agentic Team
Controlled agentic workflows for GxP operations.
USDM designs AI-assisted workflows for regulated work: bounded tasks, approved sources, human review, audit evidence, and validation controls from day one.
Operating model
Layers 1–5
Compliance posture
Part 11-aligned controls where applicable
Decision rights
Human-owned
Delivery style
Domain specialists, not bots
What this is
A controlled work-execution model, not a bot mascot.
The point is to identify which work can be safely accelerated, where the source of truth lives, what evidence must be captured, and which decisions must stay with qualified people.
Operating model alignment
Where agentic workflows fit in the AI operating model.
Agentic workflows are not the entry assessment. They are what comes after: governed, prepared, built, validated, and scaled through the same operating model used for regulated AI.
2
Prepare
Connect approved sources, permissions, data readiness, content boundaries, and system access rules.
Business outcome
Fewer source disputes, cleaner inputs, and safer retrieval.
3
Build
Configure bounded workflows for intake, retrieval, drafting, routing, comparison, and escalation.
Business outcome
Reduced cycle time and fewer manual handoffs.
4
Validate
Produce test evidence, reviewer attribution, audit trails, and Part 11-aligned handoffs where applicable.
Business outcome
Reviewable evidence that quality and compliance teams can defend.
5
Scale
Monitor output quality, exceptions, drift, change control, and portfolio governance across domains.
Business outcome
A repeatable operating model instead of one-off AI experiments.
Domain specialists
Domain specialists, not generic bots.
Each workflow is shaped by the people who own the process: quality, regulatory, clinical, manufacturing, safety, medical, security, finance, legal, HR, and operations leaders.
Quality operations
Quality
USDM designs agents to handle bounded quality work: intake, pattern matching, evidence assembly, and follow-up routing while quality owners retain approval authority.
Review workflow exampleRegulatory intelligence
Regulatory Affairs
Agents can gather source content, build change-impact packs, and organize submission inputs while the regulatory owner decides what is fit for filing.
Review workflow exampleClinical operations
Clinical Development
The goal is not autonomous clinical decision-making; it is reliable coordination, summarization, and document prep around sponsor-owned workflows.
Review workflow exampleManufacturing operations
Manufacturing
Agents help manufacturing teams make sense of routine records and exceptions while process owners remain responsible for release and disposition decisions.
Review workflow examplePharmacovigilance
Safety / PV
Agents can pre-sort submissions, draft narratives, and gather references, but safety assessment always stays with trained humans.
Review workflow exampleMedical information
Medical Affairs
USDM keeps the workflow grounded in approved content and human review so medical information stays accurate, current, and defensible.
Review workflow exampleSecurity and third-party risk
Cybersecurity & TPRM
Agents help security and procurement teams gather the facts, but humans still decide risk acceptance, remediation, and vendor go-live.
Review workflow exampleFinance, legal, HR, and operations
Corporate Functions
Corporate teams get speed on intake, routing, and summarization while approvals, policy decisions, and sensitive actions remain human-owned.
Review workflow exampleWhat agents do
Useful work inside boundaries.
Classify intake and route work to the right queue.
Retrieve approved source records and cite where each claim came from.
Draft summaries, packets, responses, and follow-up tasks for review.
Compare records, identify gaps, and escalate exceptions.
Monitor queues, missing evidence, aging items, and recurring patterns.
What agents do not do
No surprise automation.
Approve regulated records or replace required reviewer sign-off.
Make release, disposition, medical, safety, or risk-acceptance decisions.
Invent citations, commitments, dates, references, or source evidence.
Bypass QMS, RIM, CTMS, eTMF, MES, PV, or TPRM approval workflows.
Change vendor status, access rights, or controlled records without human approval.
Controls built into the workflow
Part 11-aligned where applicable. CSA-minded by design.
USDM does not claim an agent is magically compliant. We design the workflow, system handoffs, evidence, and operating procedures so regulated use can be validated, reviewed, and controlled.
Intended use and risk classification before build.
Approved source boundaries and role-based permissions.
Human approval gates for material decisions and regulated outputs.
Prompt, source, output, and reviewer-action audit trail.
Reviewer attribution and e-signature handoff where applicable.
Risk-based validation evidence aligned to CSA/GAMP principles.
Change control for prompts, models, rules, sources, and workflows.
Ongoing monitoring for quality, exceptions, drift, and adoption.
Start practical
Pick one bounded workflow and prove the control stack.
The right first use case is narrow, valuable, source-grounded, and reviewable. USDM helps map the workflow, validation scope, operating roles, and evidence package before anyone pretends it can scale.
Talk to an agentic AI specialist
Design the governed operating model your team needs.
USDM can help define the workflow, the validation scope, and the oversight controls — so the first use case is worth automating and audit-ready from day one.
- Agentic team design scoped to your domain and regulatory context
- GxP-validated AI agents with human-in-the-loop controls
- Audit trails from prompt to approval for every agent action
- Operates inside your existing systems: QMS, Veeva, ServiceNow, ERP