vGenixOS / Intelligence as a Service
Intelligence
as
APIs & MCP servers
Take the intelligence behind every vGenix Ai module, from case validity and coding to signal evidence and E2B (R3) checks, and use it in your own systems through REST APIs, or in your own AI agents through vGenix MCP servers. Every call is governed by vGenixOS and every answer comes with its evidence.
Use the intelligence without changing your platform
Most safety organisations already have a safety database, workflow tools and, increasingly, their own AI assistants. Replacing them is slow and risky. IntaaS lets you add vGenix Ai intelligence exactly where it helps, one capability at a time.
The same intelligence, unbundled
Each vGenix Ai module is built from capabilities: check validity, find duplicates, suggest coding, screen literature, detect signals, validate E2B (R3). IntaaS exposes those capabilities individually, running on the same vGenixOS engine as the platform.
APIs for systems, MCP for agents
Your systems call REST APIs. Your AI assistants and agents connect to vGenix MCP servers through the open Model Context Protocol, so they can use governed safety tools instead of guessing.
19 capabilities across five modules
Every capability is available as a REST endpoint and as an MCP tool. Each one draws on the four vGenixOS intelligences, Pharmacovigilance, Document, Regulatory and Compliance, and each one knows when to hand over to a person.
| Capability | REST endpoint | MCP tool | Intelligence used | When uncertain or SOP-required |
|---|---|---|---|---|
| Classify a document | POST /case/classify |
classify_document |
Document
|
Automatic, logged |
| Check validity (four minimum criteria) | POST /case/validity |
check_validity |
DocumentPharmacovigilance
|
Routes to a person |
| Find possible duplicates | POST /case/duplicates |
find_duplicates |
Pharmacovigilance
|
Routes to a person |
| Extract case data with source links | POST /case/extract |
extract_case_data |
Document
|
Automatic, logged |
| Suggest MedDRA and product coding | POST /case/code |
suggest_coding |
Pharmacovigilance
|
Routes to a person |
| Check a narrative against the case | POST /case/narrative-check |
check_narrative |
PharmacovigilanceCompliance
|
Automatic, logged |
| Capability | REST endpoint | MCP tool | Intelligence used | When uncertain or SOP-required |
|---|---|---|---|---|
| Screen search results for relevance | POST /literature/screen |
screen_records |
Pharmacovigilance
|
Routes to a person |
| Identify cases in an article | POST /literature/identify-cases |
identify_cases |
DocumentPharmacovigilance
|
Routes to a person |
| Check EMA literature monitoring scope | POST /literature/mlm-scope |
check_mlm_scope |
Regulatory
|
Automatic, logged |
| Extract case data from full text | POST /literature/extract |
extract_article_case |
Document
|
Automatic, logged |
| Capability | REST endpoint | MCP tool | Intelligence used | When uncertain or SOP-required |
|---|---|---|---|---|
| Run disproportionality and trend detection | POST /signals/detect |
detect_signals |
Pharmacovigilance
|
Automatic, logged |
| Cluster related cases and terms | POST /signals/cluster |
cluster_cases |
Pharmacovigilance
|
Automatic, logged |
| Build a signal evidence pack | POST /signals/evidence-pack |
build_evidence_pack |
PharmacovigilanceDocument
|
Routes to a person |
| Capability | REST endpoint | MCP tool | Intelligence used | When uncertain or SOP-required |
|---|---|---|---|---|
| Reconcile listings with the source data | POST /reports/reconcile |
reconcile_listings |
Compliance
|
Routes to a person |
| Draft a section with source links | POST /reports/draft-section |
draft_section |
PharmacovigilanceRegulatory
|
Routes to a person |
| Verify statements against data | POST /reports/verify |
verify_statements |
Compliance
|
Automatic, logged |
| Capability | REST endpoint | MCP tool | Intelligence used | When uncertain or SOP-required |
|---|---|---|---|---|
| Determine reportability by market | POST /submission/reportability |
determine_reportability |
Regulatory
|
Automatic, logged |
| Calculate due dates from day 0 | POST /submission/due-dates |
calculate_due_dates |
Regulatory
|
Automatic, logged |
| Validate an E2B (R3) message | POST /submission/validate-e2b |
validate_e2b |
RegulatoryCompliance
|
Automatic, logged |
Endpoint and tool names are illustrative. The final catalogue, versions and availability are confirmed per agreement. [Confirm before publishing.]
Every answer carries its own evidence
Whether your system calls the API or your AI agent calls an MCP tool, the answer looks the same: a result you can use and the evidence to check it. That is what makes IntaaS usable in a validated process.
# Illustrative interface POST /v1/case/validity Authorization: Bearer <token> Content-Type: application/json { "document_id": "doc_017", "rule_set": "SOP-PV-012", "market": "EU" }
{
"result": { "valid": true, "criteria_met": 4 },
"evidence": [
{ "criterion": "identifiable_patient",
"source": "page 1, line 6",
"text": "67-year-old woman" },
…
],
"rule": "SOP-PV-012 v4 · GVP Module VI, VI.B.2",
"confidence": "high",
"routing": "accept", // or "human_review"
"model_version": "case-intel 3.2.1",
"trace_id": "tr_8f2c41"
}
# Illustrative MCP client configuration { "mcpServers": { "vgenix-case": { "url": "https://mcp.[tenant].vgenix.ai/case", "auth": "oauth" } } }
# The agent calls a governed vGenix tool tool: check_validity arguments: { "document_id": "doc_017" } # The same checkable answer comes back result: valid · 4 of 4 minimum criteria evidence: source text for each criterion rule: SOP-PV-012 v4 · GVP Module VI, VI.B.2 routing: accept # uncertain → human_review trace_id: tr_8f2c41
Give your AI agents safety expertise, with guardrails
The Model Context Protocol (MCP) is an open standard for connecting AI applications to tools and data. A vGenix MCP server gives any MCP-compatible assistant or agent three things, all governed by the Pharma Control Plane.
Tools
Actions the agent can call, each with its own scope and human gate.
check_validitysuggest_codingcalculate_due_datesvalidate_e2b
Resources
Read-only context the agent can rely on, at the version in use.
- Your SOP rules for validity and seriousness
- The MedDRA version in use
- Your product dictionary
- Reporting rules by market
Prompts
Approved, version-controlled instructions for common safety tasks.
- Summarise a case for medical review
- Explain a coding suggestion
- Draft a follow-up request
- Explain why a case is reportable
Why not just give an agent a general model?
A general assistant can read a report, but it does not know your SOPs, the MedDRA version you use or your reporting rules, and it cannot show an inspector why it answered as it did. Through a vGenix MCP server, it uses governed tools that apply your rules and return evidence.
What the agent can never do
- Act outside the scope set for it in the control plane
- Skip a human gate your SOP requires
- Use an unvalidated model or prompt version
- Act without leaving an audit trail entry
Not a raw AI endpoint
IntaaS is not a language model behind an API key. Every capability runs on vGenixOS, with the same governance that makes the platform suitable for regulated work.
Pharma Control Plane
Every API call and MCP tool call passes the same controls as the platform: identity and scope, AI governance, data protection, human gates, evidence and change control.
Neurosymbolic checks
Neural AI proposes; symbolic AI checks the answer against your rules and the knowledge graph before it is returned, or routes it to a person.
The same kernels
Rules, knowledge, clock and evidence kernels sit behind every service, so an API answer matches what the platform would give.
Evidence kernel
Every call is recorded with its inputs, result, rule, model version and trace ID, ready for audit and inspection.
Versioned and validated
Services are versioned. New versions are released under change control with validation evidence, and you choose when to move. [Confirm version policy.]
Your data, your region
Data stays in the region you choose and is used only as your agreement allows. [Confirm data use policy.]
Four common starting points
Keep your safety database
Your intake portal calls classify, check_validity and
extract_case_data, then creates a pre-filled case in your existing safety database
for your team to review.
Give your safety copilot real tools
Your internal AI assistant connects to the vGenix case and submission MCP servers. A case processor asks “is this report valid, and when is it due?” and gets a governed answer with evidence.
Add literature screening to your service
A CRO calls screen_records and identify_cases inside its own
literature service, and keeps its client workflows unchanged.
Feed your signal analytics
Your analytics team calls detect_signals and build_evidence_pack on
its own data cut, and brings the results into its existing review meetings.
Two ways to use vGenixOS
Start with the service and move to the platform later, or use both. They run on the same engine.
| Area | vGenix Ai platform | Intelligence as a Service |
|---|---|---|
| What you get | Five modules, workflow, workspace and intelligence | Module intelligence as REST APIs and MCP servers |
| Where your team works | In the vGenix Ai workspace | In your own systems and AI assistants |
| Workflow and review gates | Built in, configured from your SOPs | Run in your systems; routing signals returned with every answer |
| Governance | Pharma Control Plane, audit trail, change control | The same, for every call |
| Best for | Replacing fragmented tools with one platform | Adding intelligence without changing platform |
What vGenix Ai provides
- Versioned, validated services and MCP servers
- Evidence and trace for every call
- Release notes and validation evidence for every version
- Support and service levels per agreement
What stays with you
- Your workflow and the decisions made in it
- Acting on routing signals and human gates
- Validation of your own integration
- Regulatory responsibility for your submissions
From first call to production
Choose capabilities
Pick the module capabilities that fit your process.
Sandbox
Call the APIs or connect an agent to MCP servers with sample data.
Configure and validate
Your SOP rules applied; your integration validated with our evidence.
Go live
Production access, monitoring and versioned releases.
Put vGenix Ai intelligence inside your systems
Tell us which capabilities you need and where. We’ll set up sandbox access and show you the evidence behind every answer.
6-week pilot on literature monitoring
- Baselines agreed up front
- Configured to your SOPs
- Measured on your own data
- Validation evidence from day one