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AI Compass · The 4 modules

Four modules to steer AI in a pharmaceutical company, from assessment to monitoring

AI Compass brings together four complementary modules, designed for pharmaceutical, biotech and medtech companies. Each one answers a question: where do we stand, are we compliant, what comes first, and how do we keep track over time.

Module 01

Inventory: know where you stand, and where the industry stands

Inventory maps your AI tools and benchmarks your maturity against the pharmaceutical industry. Your leadership team decides on AI investments with hard reference points: what the most advanced companies do, what you lack, where to start.

What the module does

One inventory

All your AI tools in one place, whether built in-house, purchased or embedded in your existing software.

Maturity benchmarked against the industry

Your profile dimension by dimension (AI literacy, governance, pilots in production, champions, deployed tools, monitoring), against the industry average and the top quartile.

Adoption function by function

Medical and MSL, R&D and clinical trials, marketing and MLR review, pharmacovigilance, market access, HR and legal, finance and supply chain: where AI is in production across the industry, and in your company.

Over 200 reference use cases

A library of AI use cases deployed in the healthcare industry, sorted by function and maturity level.

Measured progress

Your maturity tracked quarter after quarter, to show the impact of your AI initiatives.

Module 02

Diagnostic: assess the compliance of each tool in 15 minutes

Diagnostic assesses each AI tool and use case against the EU AI Act, the EMA reflection paper on AI, ICH Q9 (R1), GxP, MDR/IVDR and GDPR. It is where most companies start: the first assessment is free.

What the module does

A questionnaire that fits the tool

About 15 minutes per use case. The questions adapt to the type of tool assessed and how it is used.

A score per framework

For a marketing content tool, for instance: transparency (AI Act Article 50), EMA expectations on large language models, MLR review, healthcare professional data, user training (Article 4).

Recommendations ranked by deadline

The report, sent by email, tells you what to do first and by when.

An expert chatbot

It answers your questions on the EU AI Act, the EMA and GxP, taking the latest regulatory news into account.

Take the assessment

Module 03

Roadmap: from assessment to action plan

A recommendation only helps once it is part of your quality system. Roadmap turns the assessment into a compliance plan: actions ranked by priority, with owners and deadlines.

What the module does

Templates written for pharma

Standard operating procedures (SOPs), classification sheets, AI register, AI Act Annex IV technical documentation, internal audit procedures: ready to fit into your quality management system (QMS).

A governance RACI aligned with ICH Q9 (R1)

Roles and responsibilities of the executive committee, IT, compliance, business functions and the data office.

An audit-ready file

The documentation expected by AI Act conformity assessments and MDR/IVDR audits.

Module 04

Regulations: track compliance and ROI continuously

Regulations tracks over time what the other three modules set up: the deployment of AI tools, their compliance, their performance and their ROI. AI compliance is then managed like pharmacovigilance: continuously, with alerts.

What the module does

A real-time dashboard

An overview, then the detail for each tool: compliance score by dimension, alerts on high-risk use cases.

Targeted regulatory monitoring

Publications from the EMA, the FDA, the ICH and the European AI Office, flagged when they affect your use cases.

Consultants available within 24 hours

To analyse an emerging risk or a new text.

Reports for the executive committee

Monthly and quarterly, ready to present.

Dedicated hosting as an option

Data encrypted and processed in line with GDPR; dedicated hosting in the European Union or in France, on quotation.

See the demo