CIOMS Attestation

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Independent Expert Attestation

AI built for responsible use in Life Sciences.

Quartica MARS has been independently assessed for alignment with applicable CIOMS AI guidance and EU AI Act requirements.

The assessment found that Quartica MARS meets or exceeds the applicable principles and requirements evaluated for responsible AI use in regulated Life Sciences.

The badge that means confidence in how your AI works, not just what it produces.

AI in Life Sciences needs to do more than generate accurate outputs. Organizations need to understand how AI is governed, controlled, monitored, and used within regulated processes.

An independent expert assessment of Quartica MARS evaluated its document creation workflow approach against applicable principles from CIOMS Working Group XIV guidance on AI in pharmacovigilance and applicable requirements of the EU AI Act.

The assessment concluded that Quartica MARS meets or exceeds the applicable principles and requirements evaluated. That means another layer of independent assurance behind the way Quartica brings AI into regulated workflows.

Quartica MARS has been assessed by an independent expert as compliant with all of the CIOMS XVI AI in PV principles and aligning with the EU AI Act.

Evaluated to be Responsible AI, built into the workflow. 

The assessment examined Quartica MARS in the context of responsible AI expectations for regulated environments, including: 

Governance

Structured controls for how AI is managed within regulated processes.

Transparency

Greater visibility into how AI is used and how outputs are handled.

Human Oversight

Keeping qualified experts in control of review, validation, and decisions.

Accountability

Clear ownership and controls around AI-assisted processes. 

Risk Management 

Designed to identify and manage risk as AI becomes part of everyday work. 

Reliability & Traceability

Connected workflows and traceable outputs that support defensibility and audit readiness.

Why it Matters

As Life Sciences organizations move AI from experimentation into production, the questions change from “Can AI do the work?” to “Can we responsibly govern the AI doing the work?”. Quartica MARS was designed around that second question from the beginning.

Its AI operates within governed workflows, human-in-the-loop controls, regulatory intelligence, and traceability so organizations can adopt AI without giving up scientific oversight, quality, compliance, or control.

The result: AI that is not simply capable, but designed for the realities of regulated Life Sciences.

AI experimentation phase:

“Can AI do the work?”

AI in Production:

“Can we responsibly govern the AI doing the work?”

The result:

AI that is not simply capable, but designed for the realities of regulated Life Sciences.

Independently evaluated by an industry expert. 

The assessment was conducted by a member of CIOMS Working Group XIV.

Following their evaluation, our expert provided an independent expert attestation concluding that Quartica MARS meets or exceeds the applicable CIOMS guidance and EU AI Act requirements evaluated as part of the assessment.

“Responsible AI in life sciences requires more than powerful models. It requires governance, transparency, traceability, appropriate human oversight and controls that allow organizations to confidently use AI within regulated processes.” Member, CIOMS Working Group XIV

Member, CIOMS Working Group XIV

Quartica MARS customers can move forward with confidence.

As Life Sciences organizations move AI into regulated production use, they need confidence not only in what AI produces, but in how that work is governed.

The independent attestation provides additional assurance that the architecture and governance behind Quartica MARS have been evaluated against emerging expectations for responsible AI in regulated environments.

Confidence isn’t created at the end of the process. It’s built into every step along the way. That’s how Quartica MARS turns AI capability into AI you can trust. 

Compliance-grade AI. One connected workflow. Human expertise in control.

Independent Assessment Disclaimer

This assessment represents an independent expert attestation and is not a regulatory certification, regulatory approval, or formal certification by CIOMS or the European Union. A CIOMS member conducted the assessment in his capacity as an independent industry expert. His membership in CIOMS Working Group XIV is provided as professional background and should not be interpreted as an endorsement, approval, or certification of Quartica or MARS by CIOMS.

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