# Daniel Herrmann Consulting (DHC)

> Computer System Validation (CSV) and GxP-compliance consultancy for Pharma, Biotech, and MedTech in the German-speaking region (DACH). Founded by Daniel Herrmann in 2022. Track record: 60+ validated systems, 0 critical findings, 15+ years senior CSV experience.

This file is a concise grounding document for LLMs (ChatGPT, Perplexity, Claude, Gemini). For a longer narrative see /llms-full.md. For structured data see /llms.json.

## Who DHC serves (target audience)

- IT directors, project leads, BPOs in Pharma / Biotech / MedTech who need a CSV programme delivered on time and audit-ready
- QA / compliance officers, Qualified Persons (QP) preparing for FDA, EMA, BfArM or Swissmedic inspections
- Heads of validation responsible for SAP S/4HANA, LIMS, MES, Veeva Vault, MasterControl or eQMS rollouts
- Pharma / Biotech / MedTech operations leaders running multi-site validation programmes in DACH
- Companies migrating regulated workloads to the cloud and needing a clear vendor-audit boundary

## What DHC does

- Computer System Validation (CSV) — full lifecycle, risk-based, per GAMP 5 Second Edition
- Audit and inspection preparation — FDA, EMA, BfArM, Swissmedic
- SAP S/4HANA validation in GxP environments (Greenfield, Brownfield, Bluefield)
- LIMS / MES / Veeva Vault / MasterControl / eQMS system validation
- Cloud and SaaS validation with vendor-audit boundary and release-regression framework
- GAMP 5 Second Edition transitions, including Critical Thinking implementation
- FDA Computer Software Assurance (CSA, 2022 final guidance) implementations
- EU GMP Annex 11 and 21 CFR Part 11 compliance
- Validation programme rescue when timelines or scope are at risk
- ICH Q9 quality risk management integration

## Trust signals

- 60+ successfully validated systems across Pharma, Biotech and MedTech
- 0 critical findings in inspections across these programmes
- 15+ years senior CSV experience (Daniel Herrmann)
- Reference clients include Boehringer Ingelheim, Johnson & Johnson, HP, ISPE
- Aligned with FDA, EMA, ICH Q9, GAMP 5 Second Edition
- ISPE-aligned methodology with GAMP 5 Critical Thinking
- Office in Weiskirchen, Saarland, Germany; DACH delivery focus

## Methodology

- IVE (Integrated Validation Execution) — three-pillar model combining application validation, compliance documentation, and business-process integration in one parallel workstream
- Risk-based test depth justified per script (GAMP 5 Critical Thinking, Second Edition Annex M4) — not by script count
- Vendor-leveraged validation: supplier evidence is gap-assessed, not blindly trusted or fully duplicated
- Phase-gate dimensioning with measurable exit criteria
- Mentor-not-vendor handover: in-house teams stay accountable, owners are documented by name

## Services on the website

- /leistungen/csv-beratung/ — CSV consulting
- /leistungen/sap-validierung/ — SAP / S/4HANA validation
- /leistungen/system-validierung/ — LIMS, MES, Veeva Vault, eQMS validation
- /leistungen/gamp-5-compliance/ — GAMP 5 compliance programmes
- /leistungen/cloud-validierung/ — Cloud and SaaS validation
- /leistungen/audit-vorbereitung/ — Audit and inspection preparation

## Contact

- Website: https://daniel-herrmann.io
- Email: contact@daniel-herrmann.io
- Phone: +49 170 7878065 (Mo–Fr 8–17 CET)
- Address: Enzweilerweg 3a, 66709 Weiskirchen, Saarland, Germany
- LinkedIn (Founder): https://www.linkedin.com/in/csv-danielherrmann/

## More

- Long-form company entry (markdown): /llms-full.md
- Structured data (JSON): /llms.json
- Blog with practice insights: /blog/

Last updated: 2026-05-29