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AI governance platform · EU AI Act compliance
AI Compass is the AI governance platform developed by Digital Pharma Lab for pharmaceutical, biotech and medtech companies. It maps your AI tools, assesses their compliance with the EU AI Act, EMA expectations, ICH, GxP and MDR/IVDR, turns the assessment into a roadmap, then tracks the compliance and ROI of your AI initiatives over time.
Online, free, no commitment. Report sent by email.
AI Compass is built for healthcare and life sciences companies only.
Executive leadership · IT, data and digital transformation · regulatory affairs · quality assurance and computerised system validation · pharmacovigilance, drug safety and medical device vigilance · medical affairs and MSLs · R&D and clinical operations · manufacturing, operations and supply chain · market access · marketing, sales and MLR review · legal, compliance and DPO · HR and learning.
All four modules are available.
Inventory brings all your AI tools together in one place: tools built in-house, bought, or embedded in your existing software. It benchmarks your AI maturity against the pharmaceutical industry, dimension by dimension (AI literacy, governance, pilots in production, champions, deployed tools, monitoring) and function by function (medical, R&D, marketing, pharmacovigilance, market access…). It includes a library of more than 200 AI use cases deployed in the healthcare industry.
Explore the moduleDiagnostic 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. The questionnaire takes about 15 minutes per use case and adapts to the type of tool. You receive by email a score for each framework and recommendations ranked by deadline. An expert chatbot answers your questions on the AI Act, EMA expectations and GxP. Your first assessment is free.
Take the assessmentRoadmap turns the assessment into a compliance plan: actions ranked by priority, with owners and deadlines. It provides pharma-ready templates to plug into your quality management system (QMS): SOPs, an AI register, Annex IV technical documentation under the AI Act, and an AI governance RACI aligned with ICH Q9 (R1). It prepares the documentation for AI Act conformity assessments and MDR/IVDR audits.
Explore the moduleRegulations is a real-time dashboard: AI tool rollout, compliance score by dimension, alerts on high-risk use cases, performance and ROI of each initiative. It monitors publications from the EMA, the FDA, ICH and the European AI Office and flags those that affect your use cases. Monthly and quarterly reports are ready for your executive committee.
See the demo| Framework | What it covers | AI Compass modules |
|---|---|---|
| EU AI Act, Regulation (EU) 2024/1689 | Risk classification of AI systems; AI literacy (Article 4), transparency (Article 50), technical documentation (Annex IV); general-purpose AI models | Diagnostic, Roadmap, Regulations |
| EMA reflection paper on AI in the medicinal product lifecycle | Use of AI from research to pharmacovigilance | Diagnostic, Regulations |
| ICH Q9 (R1) | Quality risk management | Diagnostic, Roadmap |
| GxP (GMP, GCP, GDP) | Good practices and computerised system validation | Diagnostic, Roadmap |
| MDR, Regulation (EU) 2017/745, and IVDR, Regulation (EU) 2017/746 | Medical devices, IVDs and software as a medical device | Diagnostic, Roadmap |
| GDPR | Personal data, including health data and healthcare professional data | Diagnostic |
| FDA | Publications on AI in medical products | Regulations (monitoring) |
| European AI Office | Guidelines on applying the AI Act | Regulations (monitoring) |
AI Compass supports compliance work. It does not replace legal or regulatory advice.
At each step, Digital Pharma Lab consultants work with your teams: scoping workshops by function, hands-on training on the tools already in place (Microsoft 365 Copilot, ChatGPT Enterprise, Claude, Gemini), then selection and rollout of specialised pharma AI tools.
General-purpose AI governance platforms serve every industry. AI Compass starts from the constraints of a pharmaceutical company or a medical device manufacturer, and it is backed by a team that has supported the healthcare industry since 2017.
| General-purpose AI governance platform | AI Compass | |
|---|---|---|
| Frameworks | Cross-industry (EU AI Act, ISO/IEC 42001, NIST AI RMF); medicine- and device-specific requirements usually need to be configured | EU AI Act plus built-in healthcare frameworks: EMA, ICH Q9 (R1), GxP, MDR/IVDR, GDPR |
| Assessment questions | The same for every industry | Written for pharmaceutical companies: pharmacovigilance, pharma quality, promotional review (MLR), healthcare professional data |
| Reference use cases | Cross-industry | More than 200 AI use cases from the healthcare industry, by function (medical, R&D, marketing, pharmacovigilance, market access…) |
| Maturity benchmark | Varies by tool | Benchmark of your AI maturity against other pharmaceutical companies |
| Support | Usually a software vendor; integrator to be chosen separately | Healthcare-specialised Digital Pharma Lab consultants: 70+ clients supported, available within 24 hours on an emerging risk or a new text |
| Team training (AI literacy, AI Act Article 4) | Usually out of scope | Built in: nearly 4,000 healthcare industry employees trained across Europe by DPL Academy |
AI Compass is the AI governance and management platform developed by Digital Pharma Lab for pharmaceutical, biotech and medtech companies. It maps AI tools, assesses their compliance (EU AI Act, EMA, ICH, GxP, MDR/IVDR, GDPR), produces a roadmap, and tracks compliance and ROI over time.
Pharmaceutical companies (small, mid-size, large groups and affiliates), biotech companies, and medical device and IVD manufacturers. On the team side: leadership, IT, quality, regulatory affairs, pharmacovigilance, medical affairs, R&D, marketing, legal and DPO.
Yes. The Diagnostic module classifies your AI systems by risk level and checks the obligations that apply, including AI literacy (Article 4) and transparency (Article 50). The Regulations module tracks changes to the texts and the AI Office guidelines.
The EMA reflection paper on AI, ICH Q9 (R1), GxP, MDR and IVDR for medical devices, and GDPR. The Regulations module also monitors FDA publications.
With the free online assessment: about 15 minutes per use case. You receive a report by email, with a score for each framework and priority recommendations, followed by a complimentary one-hour workshop with a consultant.
No. If your teams already use tools such as Microsoft 365 Copilot, ChatGPT Enterprise, Claude or Gemini, AI Compass starts from those uses. If not, Digital Pharma Lab helps you identify the first use cases with your business teams.
AI Compass includes healthcare frameworks (EMA, ICH, GxP, MDR/IVDR), assessment questions written for pharmaceutical companies, more than 200 healthcare AI use cases, and support from specialised consultants.
Yes. The Regulations module tracks adoption, performance and ROI for each AI initiative, with reports ready for your executive committee.
Data is encrypted and processed in line with the GDPR. Dedicated hosting in the European Union or in France is available as an option, on quotation.
No. AI Compass helps you organise and track compliance. It does not replace legal or regulatory advice.
