GxP Services
Specialized services in Computer System Validation, GxP compliance, and AI Governance for the pharmaceutical and life sciences industries.
Computer System Validation
Computer System Validation (CSV) in GxP-regulated environments is not optional — it is a mandatory demonstration that any computerized system directly impacting product quality, patient safety, or data…
Discover →Annex 11 / 21 CFR Part 11
Dalia IA Engineering Studio provides specialized gap assessment and remediation services for Annex 11 and 21 CFR Part 11 compliance, backed by 20+ years of GxP regulatory expertise.
Discover →GAMP 5 / Lifecycle / CSA
GAMP 5 — Good Automated Manufacturing Practice — Second Edition, published by ISPE in 2022, is the global standard methodological framework for the validation of software and computerized…
Discover →Data Integrity
Data Integrity — the assurance that GxP data is complete, consistent, accurate, and unaltered throughout its lifecycle — has become one of the foremost priorities of international regulatory…
Discover →AI-supported Pharmacovigilance
The integration of artificial intelligence technologies into pharmacovigilance processes introduces a set of engineering and regulatory challenges that traditional Computer System Validation frameworks do not fully address.
Discover →AI Governance & Validation
Governing AI and machine learning systems in regulated pharmaceutical, biotech, and medical device environments cannot be reduced to writing a policy or adopting a generic framework. It is…
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