Validation. Compliance. Governance.

Technical Regulatory Engineering for GxP Systems and AI in Regulated Environments

Dalia IA is an Engineering Studio specialising in Computer System Validation (CSV/CSA), GAMP 5, Annex 11, 21 CFR Part 11, Data Integrity and AI Governance for GxP regulated environments in the pharmaceutical, biomedical, biotech, medical device and CRO sectors.

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20+ years of experience
900+ systems validated
40+ active clients
Why Dalia IA

Why Dalia IA

Dalia IA is an AI platform specialised for regulated environments: not a generic assistant, but a system designed to support qualification and validation processes in compliance with European and international regulatory requirements.

Deterministic AI Modules for Critical Uses

Functions for critical GMP applications (IQ/OQ/PQ protocols, URS, risk assessment, traceability matrix) are based on deterministic and static logic, in line with the Annex 22 Consultation Guideline scope.

GenAI Tools only for Non-Critical Support

Generative tools (LLMs) are used exclusively for non-critical GMP support activities (regulatory research, technical documentation synthesis) and always with human review (human-in-the-loop). Never used for critical GMP outputs, consistent with Annex 22 limits.

Explainability and Audit Trail

Every decision generated by Dalia IA is traceable and explainable. The approach to explainability is consistent with Annex 11 audit trail requirements and with the need to justify AI choices during regulatory inspections.

Lifecycle Validation & Change Control

Support for the entire system lifecycle: from initial qualification to periodic review, change control and revalidation. Aligned with Annex 15 lifecycle requirements.

// Servizi

Servizi specializzati per ambienti regolati

Due aree di intervento ad alto valore per il settore life sciences: Validazione GxP dei sistemi computerizzati e Farmacovigilanza con supporto AI per il monitoraggio digitale.

Validazione GxP & AI

Validazione GxP & AI

Computer System Validation, AI Validation (Annex 22), GAMP 5, FDA 21 CFR Part 11, Annex 11/15, IQ/OQ/PQ, life cycle management.

Vedi i servizi GxP
Farmacovigilanza

Farmacovigilanza

Monitoraggio digitale AI-supported di siti web e canali, in coerenza con GVP, Annex 11, 21 CFR Part 11 e GAMP 5. Evidenze tracciabili per il responsabile PV.

Vedi i servizi PV
// Servizi GxP

Soluzioni per la Validazione GxP

Servizi specializzati in Computer System Validation, AI governance, conformità normativa e gestione del ciclo di vita dei sistemi in ambienti regolati.

★ Featured Service

Pharmacovigilance Monitoring

AI-assisted operational support for pharmaceutical Drug Safety departments. Daily scheduled monitoring of websites and digital channels for QPPV, Drug Safety Managers, PV Managers. Automatic execution, dated screenshots, safety-term pre-filter, organized archive.

Learn more about Pharmacovigilance

AI System Validation in 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.

Learn more
// Regulatory Framework

Reference Standards & Regulations

Dalia IA operates in alignment with the main international regulatory frameworks for GxP environments.

Annex 11 Annex 15 Annex 22 CG EudraLex Vol.4 GAMP 5 FDA 21 CFR Part 11 EU-GMP GLP GMP GCP GDP ISO 9001 ISO 13485 ICH Q9 ICH Q10 NIS2
// AI Regulatory Framework

Regulatory Positioning of Dalia IA

AI use in regulated GxP environments requires a differentiated approach by model type and application context. Dalia IA clearly distinguishes the areas of application.

Annex 11 – EudraLex Vol.4

GMP Computerised Systems

Application validation, IT infrastructure qualification, lifecycle risk management, traceable URS, supplier assessment, periodic review, security and audit trail.

Applicable to all computerised systems used in GMP production, including AI components with deterministic logic.
Annex 15 – EudraLex Vol.4

Qualification & Validation

Lifecycle validation, URS, DQ/IQ/OQ/PQ, Quality Risk Management (QRM) and change control. Reference framework for the qualification of critical systems and processes.

Dalia IA supports the production of compliant documentation throughout the entire validation lifecycle.
Annex 22 – Consultation Guideline

AI/ML in GMP Applications

The guideline applies to static and deterministic AI/ML models in critical GMP applications. Dynamic models, probabilistic outputs, Generative AI and LLMs are out of scope for critical GMP applications.

⚠ GenAI/LLM: only for non-critical GMP uses with human-in-the-loop, not for critical GMP outputs.
Test Governance & Explainability

Transparent and Verifiable AI

Every Dalia IA AI module undergoes structured test governance: test set definition, performance validation, output traceability and explainability documentation to support regulatory inspections.

Consistent with audit trail requirements (Annex 11, ch. 9) and intended use documentation (Annex 22).

Deterministic / Static AI

For critical GMP applications – Annex 22 scope

  • Generation of structured IQ/OQ/PQ protocols
  • FMEA/FMECA risk classification
  • Regulatory gap analysis (fixed rules)
  • Automated traceability matrix
  • Annex 11/15 compliance checklists
  • Validation with fixed test set and reproducible results

Generative AI / LLM

Only for non-critical support – human-in-the-loop required

  • Synthesis and search of regulatory documentation
  • Descriptive drafts of non-critical sections
  • Support for SOP drafting (human review required)
  • Q&A on regulations for the quality team
  • Generation of internal informational reports
  • Not used for critical GMP data or regulatory decision making

Fonti: Annex 11 · Annex 15 · Annex 22 CG · EudraLex Volume 4

// Settori

Settori di Applicazione

Operiamo in tutti i settori regolati dove la validazione dei sistemi informatici e l'AI governance sono requisiti normativi.

Farmaceutico & Biotech

GMP produzione, confezionamento, laboratori QC, batch record elettronici

Dispositivi Medici

ISO 13485, MDR, progettazione, fabbricazione e post-market surveillance

Cosmetica & Alimentare

HACCP, GMP cosmetico, tracciabilità e conformità normativa europea

GLP / GCP / GDP / GVP

Studi clinici, farmacovigilanza, distribuzione controllata

Laboratori R&D

LIMS, strumentazione di laboratorio, data integrity e GLP

Andrea Giampellegrini
// Il Fondatore

Andrea Giampellegrini

Fondatore & Validation Engineer – Dalia IA

Ingegnere specializzato in Qualifica e Validazione di Sistemi Informatici in ambienti regolati GxP, con oltre 20 anni di esperienza nel settore farmaceutico, biomedicale, biotecnologico e dei dispositivi medici.

Ha supervisionato la validazione di oltre 900 sistemi e lavora con oltre 40 clienti attivi tra aziende multinazionali e PMI italiane su progetti di Computer System Validation, AI governance, implementazioni ERP e compliance normativa (Annex 11, Annex 15, Annex 22, GAMP 5, FDA 21 CFR Part 11).

Dalia IA nasce dalla sua visione: applicare le tecnologie AI in modo rigoroso e normativo nei processi di qualifica e validazione, mantenendo la piena tracciabilità e la conformità alle linee guida europee per i sistemi computerizzati GxP.

Nota: Andrea Giampellegrini è anche titolare dello Studio di Ingegneria AG. Per consulenze tradizionali: www.ingag.it
// Blog Tecnico

Approfondimenti su AI, Normative e GxP

Articoli tecnici su AI governance, multimodale AI, GenAI in ambito sanitario, explainability, validazione e trend 2025.

Tutti gli articoli
// Contact

Let's talk about your project

Fill out the form to request a consultation on AI validation, CSV, Annex 11/15/22 or any other GxP project. We will reply within 24 working hours.

Sede

San Giuliano Terme, Toscana, Italia