Life sciences technology decisions need clear record boundaries.

Pharma, biotech, and medical device organizations need to establish which systems hold regulated records and who owns validation. That boundary shapes the ERP decision. If AI enters a GxP workflow, it adds a separate governance question. Lightbridge.ai routes the accounting and operating-system requirements to ERP and the AI oversight work to Automation.

Lightbridge ERP covers regulated operations and research accounting

Detailed requirements live in the Lightbridge ERP life sciences practice. It covers regulated-record boundaries, lot genealogy, computer system validation, and R&D accounting. The selection process examines quality-system interfaces alongside purchasing, manufacturing costs, and research spending. Bring a record map and representative lot histories to show where the ERP would receive, create, or retain controlled information.

Lightbridge Automation governs AI use in regulated workflows

For an AI use case touching a GxP environment, Lightbridge Automation's AI governance consulting is the relevant practice. Its work includes responsible AI frameworks and ISO 42001 readiness. Scope the intended use, accountable reviewers, and evidence needed to monitor the model. This is a route to AI governance expertise; the quality team still determines the validation obligations for the specific workflow.

ISO 42001 readiness is a consulting service, not a claim of Lightbridge certification or a substitute for applicable GxP requirements.

Use this page for orientation, not regulatory, clinical, legal, or accounting advice.