Pharma & Life Sciences

Advance the science. Defend the decision.

Connect AI actions in quality, research and regulated operations to the rules and people responsible for them.

The operating reality

The next AI action could change the status of an entire batch.

Illustrative runtime film
Illustrative workflow

Keep batch release under quality oversight.

Illustrative example, not a customer deployment.

ILLUSTRATIVE RUNTIME WORKFLOW
Agent
Quality operations agent
Requested action
Change a batch from pending to released
Authorization check
Has an authorized quality reviewer approved the release?
Outcome
Hold the change for review and record the decision.
How it works

Built for regulated evidence.

From system validation and data integrity to adverse-event workflows and submission evidence.

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GxP integrity

Attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available evidence.

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Pharmacovigilance

Traceable findings, source facts, classifications, escalation, and Human in the Loop decisions.

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Validated systems

Controlled versions, audit trails, electronic records, and reproducible decision evidence.

Control and evidence coverage

Mapped to the requirements that govern the system.

GxPGAMP 5ALCOA+Annex 11Draft Annex 2221 CFR Part 11GVP

Move from governance claims to defensible evidence.

Book a briefing to see how Nextvise protects AI actions in your environment.

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