Daniel Herrmann Consulting is a specialized consultancy for Computer System Validation (CSV) in the pharmaceutical and life sciences industry. We validate computerized systems risk-based, audit-proof, and in half the industry-standard project timeline.
Our expertise covers the full scope of GxP validation: from validation strategy through IQ/OQ/PQ to go-live. We work according to GAMP 5 2nd Edition, Computer Software Assurance (CSA), and the regulatory requirements of FDA 21 CFR Part 11 and EU Annex 11.
Our core services:
→ CSV Consulting — end-to-end validation for SAP S/4HANA, Veeva Vault, LIMS, MES, ERP, and Cloud/SaaS systems
→ GxP Compliance & Audit Readiness — gap analysis, remediation, mock inspections, audit trail review
→ SAP S/4HANA Validation & Cutover Management — multi-site rollouts, data migration, test management
→ Go-Live Rescue — rapid deployment teams when project timelines are at risk
→ CSA Transformation — GAMP 5 alignment, framework redesign, staff training
→ Data Integrity (ALCOA+) — audit trail review, data governance, 21 CFR Part 11 compliance
What sets us apart: Performance System Validation. We validate with precision and maximum efficiency — not documentation for documentation's sake, but focused on what truly matters for quality, patient safety, and audit readiness.
60+ validated systems · 8+ countries · 0 critical audit findings · 50% faster than industry standard
Trusted by Boehringer Ingelheim, Johnson & Johnson, and HP.
System go-live approaching? Let's talk: daniel-herrmann.io

Daniel Herrmann Consulting

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Daniel Herrmann Consulting

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