CSV & GxP advisory
Computer system validation and GxP advisory for Business Central
Scoping, risk-based assessment, and audit preparation for computerized systems - so your Business Central estate holds up under GxP scrutiny.
TrustFort provides computer system validation (CSV/CSA) and GxP advisory for Microsoft Dynamics 365 Business Central and the systems around it. We apply GAMP 5 categorization and a risk-based approach so validation effort lands where the patient- and product-risk actually is - not as an undifferentiated documentation exercise.
The work is independent of implementation: we scope, assess, and prepare the evidence, regardless of who delivers the configuration. The result is a defensible validation position aligned to EU GMP Annex 11, the new Annex 22, 21 CFR Part 11, and ALCOA+ data integrity.
What we cover
Validation scoping and planning
GAMP 5 categorization and a risk-based CSV/CSA scope, captured in a validation plan your quality function can defend.
Gap and data-integrity assessment
An assessment of your current landscape against Annex 11, Annex 22, 21 CFR Part 11, and ALCOA+.
Audit and inspection preparation
The documentation and evidence a regulated inspection expects, prepared before the audit asks.
Validation scoping and planning
- GAMP 5 software categorization for Business Central and its integrations
- Risk-based scope: critical thinking on patient, product, and data risk over blanket testing
- Validation plan, requirements traceability, and a proportionate test strategy
Gap and data-integrity assessment
- Compliance gaps against EU GMP Annex 11 and the new Annex 22 (AI) expectations
- 21 CFR Part 11 electronic records and signatures review
- ALCOA+ data-integrity assessment across records, audit trails, and access
Audit and inspection preparation
- Validation documentation and requirements-to-evidence traceability
- Audit-trail review and inspection-readiness walkthroughs
- Remediation priorities framed as support for audit readiness - not a compliance guarantee
How we deliver
- Time-boxed engagements - scoping and assessments measured in days, not open-ended retainers.
- A written deliverable at the end of each engagement: validation scope or assessment findings, documentation, and a prioritized remediation roadmap.
- Senior involvement throughout. The people who assess are the people who deliver.
Clarify your validation scope
If you are planning a validation, preparing for an inspection, or unsure whether your data integrity holds up, we offer a focused discussion to clarify scope and next steps.