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.
A requirement-by-requirement mapping of FDA 21 CFR Part 11 and EU GMP Annex 11 to Business Central: what each rule requires, how it is met by configuration, and what validation evidences it.
Read article →Can SharePoint and Microsoft 365 meet FDA 21 CFR Part 11 for electronic records and signatures? What the platform provides, what needs configuration and validation, and who is responsible.
Read article →Configure, validate and evidence 21 CFR Part 11 electronic-records and e-signature controls in Microsoft Dynamics 365 Business Central - ready for FDA inspection.
Read article →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 →How ALCOA+ data integrity principles map to Microsoft Dynamics 365 Business Central configuration. Practical guidance for regulated ERP environments.
Read article →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 →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 →Every Business Central filter operator with examples - ranges (..), wildcards (* and ?), OR, exclusions (<>), comparisons and how to combine them into precise list filters.
Read article →Business Central can support cosmetics and nutraceutical manufacturers, but regulators expect GMP-grade traceability and quality control the ERP must be configured and validated to provide.
Read article →Business Central supports food & beverage manufacturers with lot tracking and recall readiness, but effective traceability and recall speed depend on configuration aligned to FSMA and EU food law.
Read article →Business Central can be the ERP backbone for medical device manufacturers, but it is not compliant out of the box. ISO 13485, 21 CFR Part 820, Part 11, and MDR traceability are met through configuration and validation.
Read article →Business Central is widely used by pharmaceutical manufacturers, but it is not GMP-compliant out of the box. Annex 11, 21 CFR Part 11, ALCOA+ data integrity, and batch traceability are met through configuration and validation.
Read article →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 →Every Microsoft Dynamics 365 Business Central keyboard shortcut for Windows and Mac - navigation, data entry, list filtering, posting, dates and the role explorer.
Read article →Yes, AI agents can be used in a validated ERP system, but only under governance: approval gates, human-in-the-loop, audit trails, and change control under Annex 11 and Annex 22.
Read article →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 →A phase-by-phase ERP implementation checklist for regulated manufacturers using Business Central: scoping, supplier qualification, data integrity, validation (IQ/OQ/PQ), and go-live controls.
Read article →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 →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 →GxP validation protocol template for Business Central: URS, IQ, OQ, PQ, traceability and summary-report structure to adapt by risk - a starting point, not a finished protocol.
Read article →No, Business Central is not 21 CFR Part 11 compliant out of the box. Part 11 compliance for electronic records and signatures is achieved through configuration and validation.
Read article →No, Microsoft Dynamics 365 Business Central is not GxP compliant out of the box. GxP compliance is achieved through risk-based configuration and computer system validation.
Read article →Microsoft ended mainstream support for Dynamics NAV 2016 in April 2026. What regulated manufacturers need to do now. Practical migration roadmap to Business Central.
Read article →EU GMP Annex 22 sets expectations for AI in GMP. For ERP systems it means AI features and agents need defined boundaries, human oversight, audit trails, and validation.
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