COMPLIANCE FAQ

Compliance agents, questions answered.

The agents read your records, find the exceptions and show their reasoning. The decisions stay with your people.

FAQ

Common Questions

All FAQs →

Does this replace our quality management system?

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No. It reads the quality system and the rest of the landscape and correlates them. Your systems of record do not change.

How can an AI system be validated?

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The rules that decide are deterministic, versioned and testable. The model retrieves and explains. The audit trail is append-only.

Who is accountable if something is missed?

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Your reviewer, exactly as today. The system shortens the queue and shows its reasoning for every finding.

What if our data is messy?

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That is the normal starting point. Extractions carry a confidence score, and anything below the threshold goes to a person.

We cannot give system access yet.

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Start with a spreadsheet export. No integration is needed to see the workspace running on your own data.

Can it run inside our own environment?

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Yes. Decide this before the build, not after.

What does it cost?

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It depends on your sources, volumes and hosting. We discuss it with your numbers in a working session.

What the agents never do

Release, certify or disposition a batch

Close a deviation, investigation or CAPA

File anything with an authority

Write to your systems outside the transitions you approve

Send a message without a named person's approval

Contact a regulatory authority or a customer

Promote itself to a higher autonomy level

Make you compliant. Compliance decisions and accountability stay with you.

Bring one batch.

Send an export for one batch or lot and see the workspace run on your own data.