GxP Validation Guide for Business Central

Free guide for regulated manufacturers: Annex 11, GAMP 5, 21 CFR Part 11, Annex 22 AI — proven for pharma, MedTech and cosmetics.

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What you will learn

  • Why Business Central is GxP-relevant in regulated environments
  • Regulatory framework: Annex 11, GAMP 5, 21 CFR Part 11, Annex 22
  • GAMP 5 classification for BC Cloud and extensions
  • Validation lifecycle from URS to summary report
  • Governance model for ongoing operations
  • AI in regulated environments: Annex 22 and GAMP 5 AI Guide

Who this guide is for

QA Manager / Validation Manager

You oversee computerized system validation and need a practical reference.

IT Manager / ERP Lead

You implement or maintain Business Central in regulated environments.

Regulatory Affairs / Compliance

You ensure GxP compliance of IT systems and prepare for audits.

Why TrustFort?

TrustFort IT Consulting specializes in GxP validation of Dynamics 365 Business Central for regulated manufacturers in pharma, MedTech, and cosmetics. References in DACH, Nordics, USA, and Hong Kong. Microsoft Partner.

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