# dhc — CSV Consulting (LP grounding · short)

URL: https://daniel-herrmann.io/leistungen/csv-beratung/
Updated: 2026-06-01 · Language: English · DE: /leistungen/csv-beratung/llms.txt

## Service
Computer System Validation (CSV) for Pharma, Biotech, MedTech in DACH. Boutique consultancy with mentor model — in-house teams stay accountable.

## Audience
IT directors, project leads, BPOs, validation managers, QA leads, Qualified Persons.

## Methodology
IVE — Integrated Validation Execution. Three streams (Application, Compliance, Business) in parallel from day 1. GAMP 5 Second Edition with Critical Thinking, risk-based instead of script-count-driven.

## Track record (self-reported)
60+ validated systems · 100% audit pass rate · 0 critical findings · 15+ years of senior practice.

## Standards
ISPE GAMP 5 (2nd Edition 2022) · FDA CSA Final Guidance (2022) · 21 CFR Part 11 · EU GMP Annex 11 · ICH Q9(R1).

## Engagement models
Strategic advisory · Full programme delivery · Embedded mentoring.

## Long-form
/leistungen/csv-beratung/en/llms-full.md

— Daniel Herrmann Consulting · Weiskirchen, Germany