One inventory
All your AI tools in one place, whether built in-house, purchased or embedded in your existing software.
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AI Compass · The 4 modules
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.
Online, free, no commitment. Report sent by email.
Module 01
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
All your AI tools in one place, whether built in-house, purchased or embedded in your existing software.
Your profile dimension by dimension (AI literacy, governance, pilots in production, champions, deployed tools, monitoring), against the industry average and the top quartile.
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.
A library of AI use cases deployed in the healthcare industry, sorted by function and maturity level.
Your maturity tracked quarter after quarter, to show the impact of your AI initiatives.
Module 02
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
About 15 minutes per use case. The questions adapt to the type of tool assessed and how it is used.
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).
The report, sent by email, tells you what to do first and by when.
It answers your questions on the EU AI Act, the EMA and GxP, taking the latest regulatory news into account.
Module 03
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
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).
Roles and responsibilities of the executive committee, IT, compliance, business functions and the data office.
The documentation expected by AI Act conformity assessments and MDR/IVDR audits.
Module 04
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
An overview, then the detail for each tool: compliance score by dimension, alerts on high-risk use cases.
Publications from the EMA, the FDA, the ICH and the European AI Office, flagged when they affect your use cases.
To analyse an emerging risk or a new text.
Monthly and quarterly, ready to present.
Data encrypted and processed in line with GDPR; dedicated hosting in the European Union or in France, on quotation.