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Regulated Data & AI Engineering

AI Production & Assurance

Move AI from prototype to controlled production with integration, evaluation and technical governance controls.

Define the workflow

Define production architecture, system boundaries, data flows and access controls. Integrate the AI workflow with existing infrastructure and agree human oversight responsibilities.

Engineer the system

Implement evaluation criteria, failure and hallucination tests, prompt/model regression checks and traceable logs as required by the use case. Assess results against agreed acceptance thresholds.

Review and operate

Prepare deployment, documentation, operational procedures and handover. Scope model/vendor inventories, monitoring instrumentation, cost/performance checks and AI Act documentation support to the project. Ongoing operation is not included.

Agreed engineering deliverables

  • Evaluation dataset, quality thresholds and evaluation report
  • Regression tests, access model and logging configuration
  • Deployment procedures, documented limitations and handover guidance

Designed to support validation under the customer’s quality system. Validation responsibilities, acceptance criteria and human review are agreed explicitly; automation does not replace accountable quality review.

Case Studies

Selected engineering projects

Anonymized project experience in Financial Services, Life Sciences and self-hosted AI automation, with concrete approaches, results and lessons learned.

Technologies and standards chosen for the workflow

Statistical computing

R · Python · SAS · SQL

Clinical workflows

CDISC · SDTM · ADaM · Pinnacle 21 · TLF

Private AI

LLMs · RAG · on-premise · private cloud

Applications

Shiny · APIs · dashboards

Required inputs

Intended use, representative evaluation questions, approved knowledge sources, current prototype and infrastructure constraints.

Customer responsibilities

Provide domain reviewers, approved data access and owners for human oversight and operational decisions. Agree permitted model providers and data locations.

Acceptance criteria

Agree task-specific quality thresholds and failure cases. Demonstrate access boundaries, traceable outputs and repeatable regression checks before the agreed deployment.

Contact

Discuss your workflow

Move AI from prototype to controlled production with integration, evaluation and technical governance controls.

info@leap-dynamics.com+49 (0) 30 62939513Scharnhorststraße 24, 10115 Berlin

We usually respond within two business days.

Please do not include health data, credentials, confidential records or production datasets in this initial inquiry.

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