Expertise

Navigating EU GMP, FDA, GDP and GCP requirements with clarity and confidence.

QMS, CSV, CSA and GAMP 5 approaches that are risk-based and right-sized.

Enterprise architecture and pharmaceutical IT built for regulated operations.

Applying AI responsibly where validation, governance and trust matter.

Leadership and delivery assurance for complex transformation programmes.

Senior subject-matter experts where judgement and experience are decisive.

Pharma ITDraft content

Designing a compliant enterprise architecture for pharma

VITA Author (placeholder) · Draft · 7 min read

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Architecture decisions shape how data flows between ERP, MES, LIMS and quality systems — and therefore how integrity and traceability are maintained.

A future version of this article will describe principles for compliant-by-design architecture.

Quality & Compliance

From CSV to CSA: rethinking validation through critical thinking

AI in Life Sciences