21 CFR Part 11 and Business Central — Compliance Checklist
How to meet FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in Microsoft Dynamics 365 Business Central. Practical checklist.
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Practical guides and methodology for ERP in regulated industries
TrustFort publishes independent methodology guidance for ERP implementation and compliance in regulated manufacturing environments. These guides reflect practical experience from GxP validation projects in pharmaceutical, cosmetics, and chemical production — not product marketing. Every article is written for the decision-makers accountable for ERP system integrity: heads of IT, QA managers, compliance leads, and application owners. Content is available in English, German, and Swedish.
AI in Regulated Manufacturing — Practical Guidance for Annex 22 Compliance
Practical guidance for Annex 22 compliance in regulated manufacturing. How to scope AI systems, validate models, and design human oversight workflows in Business Central environments.
Read article →ALCOA+ Principles and Business Central — Data Integrity in Regulated ERP
How ALCOA+ data integrity principles map to Microsoft Dynamics 365 Business Central configuration. Practical guidance for regulated ERP environments.
Read article →Audit Readiness Checklist for Business Central in Regulated Industries
A 20-item audit readiness checklist for Business Central in regulated industries. What inspectors look for, how to prepare your evidence package, and common findings to avoid.
Read article →Batch and Lot Management in Business Central — A Guide for Regulated Manufacturers
How Business Central handles lot and batch tracking for regulated manufacturers. Item tracking, forward and backward traceability, expiry dates, and audit-ready configuration.
Read article →Business Central for the Pharmaceutical Industry — What You Need to Know
Why pharmaceutical and cosmetics manufacturers choose Business Central, what standard BC covers for GxP, and which AppSource extensions close the gap. Independent perspective.
Read article →Computer System Validation — Step by Step for Business Central
A practical step-by-step guide to computer system validation for Microsoft Dynamics 365 Business Central in regulated industries. Document hierarchy, testing, and SaaS update management.
Read article →EU GMP Annex 22 — AI in Regulated Manufacturing and Business Central
What EU GMP Annex 22 means for pharma and medical device manufacturers using Business Central. Compliance guidance for AI systems in regulated ERP environments.
Read article →GxP Validation for Business Central — A Practical Guide
How to validate Microsoft Dynamics 365 Business Central for GxP compliance. Covers validation strategy, GAMP 5 categorisation, risk assessment, and audit trail requirements.
Read article →NAV 2016 Support Has Ended — Migration Roadmap to Business Central
Microsoft ended mainstream support for Dynamics NAV 2016 in April 2026. What regulated manufacturers need to do now. Practical migration roadmap to Business Central.
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