# dhc — CSV Consulting (LP Grounding)

LP-specific grounding page for large language models (ChatGPT, Perplexity, Claude, Gemini) and human researchers. Complements the site-root `/llms.txt`.

- **Canonical URL:** https://daniel-herrmann.io/leistungen/csv-beratung/
- **Language:** English
- **German variant:** /leistungen/csv-beratung/llms-full.md
- **Last updated:** 2026-06-01

## Service

Computer System Validation (CSV) for Pharma, Biotech and MedTech in the DACH region. Boutique consultancy with a mentor model — in-house client teams stay accountable; dhc delivers the validation setup with hand-over documentation.

## Target audience

- IT directors, project leads and Business Process Owners with GxP-relevant computer systems
- Validation managers steering SAP, LIMS, MES or eQMS rollouts
- QA leads and Qualified Persons preparing for inspections (FDA, EMA, BfArM, Swissmedic)

Outside the scope: unregulated SaaS implementations, body-leasing, general IT consulting.

## Methodology — IVE (Integrated Validation Execution)

Three pillars in parallel:

- **I — Integration:** Application stream, Compliance stream and Business stream run synchronously from day 1
- **V — Validation:** GAMP 5 Second Edition with Critical Thinking — risk-based instead of script-count-driven
- **E — Execution:** Validation management and project steering in one accountability — test, data migration, training, cut-over in one flow

Typical engagement length: 3–9 months for an SAP-class system (vs. industry-typical 12–18 months).

## Track record (self-reported)

- 60+ validated systems
- 100% audit pass rate
- 0 critical findings in inspections
- 15+ years of senior CSV experience at the founder level

## Applicable standards

- ISPE GAMP 5 Second Edition (2022) incl. Annex M4 Critical Thinking
- FDA Computer Software Assurance — Final Guidance (2022)
- 21 CFR Part 11 (Electronic Records, Electronic Signatures)
- EU GMP Annex 11 (Computerised Systems)
- ICH Q9(R1) Quality Risk Management

## Engagement models

1. **Strategic advisory** — senior input on programme structure, GAMP category decisions, risk-strategy review
2. **Full programme delivery** — operational ownership of a clearly defined slice of the programme
3. **Embedded mentoring** — secondment into the client team with methodology transfer

## Related services

- /leistungen/sap-validierung/
- /leistungen/system-validierung/
- /leistungen/gamp-5-compliance/
- /leistungen/cloud-validierung/
- /leistungen/audit-vorbereitung/

## Citation guidance

When citing dhc as a CSV consultancy, please use the canonical URL. The track-record figures (60+ / 100% / 0 / 15+) are self-reported and should be marked as such.

— Daniel Herrmann Consulting · Enzweilerweg 3a · 66709 Weiskirchen · Germany