Need help getting started
Step-by-step instructions, written by the people who built the product.
Visit our Getting Started guideSupport
Send us a message if you have any questions. We are quick to answer.
Frequently asked questions
You may find some of your questions answered already. Take a look.
General
Is ComplAi customizable to meet our unique business needs and workflows?
Yes, one of ComplAi’s strengths is its flexibility. It can be easily customized to align with your specific business processes, ensuring a personalized solution that seamlessly integrates into your existing workflow.
Can ComplAi be used both internally and externally?
Yes, ComplAi is designed to be a flexible solution, catering to both internal processes and external interactions. Whether managing internal compliance or engaging with external stakeholders, ComplAi is your reliable companion.
How does ComplAi contribute to a more sustainable and eco-friendly operation?
ComplAi’s paperless processes and energy-efficient design contribute to a more sustainable operation. By reducing the need for physical paperwork and optimizing resource utilization, ComplAi aligns with environmentally conscious business practices.
How does ComplAi facilitate collaboration among team members?
ComplAi promotes collaboration by providing a centralized platform for information sharing, task delegation and document management. Its collaborative features enhance team communication and streamline cooperative efforts for greater efficiency.
Can ComplAi adapt to changes in regulations and update our processes accordingly?
Absolutely! ComplAi is equipped with intelligent learning capabilities, allowing it to adapt to changes in regulations swiftly. This ensures that your processes remain up-to-date and compliant, reducing the risk of regulatory issues.
Manufacturers
Which regulations does the pre-flight check cover?
Any regulation, on request. ISO 27001 is ready to go; for EU MDR, IVDR or another standard, sign up for the pre-flight check, tell us which one you need, and we’ll set it up for you.
Why not use a general AI assistant?
It can summarise a document; it cannot assess a 3,000-document dossier the same way twice. ComplAi uses machine-readable requirements and cites every finding.
Does AI decide whether my file is compliant?
No. ComplAi prepares the analysis; your RA/QA team decides what to change, and the notified body makes the conformity decision.
Where is our data hosted?
All data is hosted in the EU. ComplAi is ISO 27001 certified and GDPR compliant.
Notified bodies
Does AI make conformity decisions?
No. ComplAi assists assessors; every decision and signature stays with them. Our use of AI follows UKAS and DAkkS guidance for AI in conformity assessment: human oversight, cited evidence and a full audit trail.
How do you protect manufacturer files?
Secure data rooms with access control and a complete audit trail. ComplAi is ISO 27001 certified and GDPR compliant.
How is the AI validated, and how does it fit the EU AI Act?
Every answer is grounded in the submitted documents and cited to the source passage, results are reproducible, and a human reviews every output — in line with UKAS and DAkkS guidance.
Regulatory consultants
Will this reduce what I can bill?
It changes what you bill for. Less time on reading means capacity for more clients and room for productised, retainer-style assessment — with a cited audit trail that justifies the fee.
Why not upload documents to a generic AI assistant?
A general assistant is fast but inconsistent and hard to trace. ComplAi checks against machine-readable requirements, gives the same result every time, and cites every finding to the exact passage.
Do my clients’ notified bodies need to use ComplAi?
No. You can work with your clients alone, and connect to the same data rooms when the notified body is on ComplAi.
Where is client data hosted?
All data is hosted in the EU. ComplAi is ISO 27001 certified and GDPR compliant.
Supplier assessment & data collection
Can we use our own questionnaire?
Yes. You invite each supplier into a collaborative data room with your own questionnaire enabled, or configure one standard.
Where is supplier data hosted?
All data is hosted in the EU. ComplAi is ISO 27001 certified and GDPR compliant.