# dhc — Audit & Inspection Preparation (LP grounding · short)

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

## Service
Preparation and on-day support for FDA, EMA, BfArM and Swissmedic inspections.

## Three-layer model
L1 Documents (the binder) · L2 Process (the workflow) · L3 People (the interview).

## Engagement
Pre-inspection walkthrough · mock audit · dossier completion · on-day support. Typical lead time: 6–8 weeks.

## Standards
GAMP 5 Second Edition · 21 CFR Part 11 · EU GMP Annex 11 · ICH Q9(R1).

## Long-form
/leistungen/audit-vorbereitung/en/llms-full.md

— Daniel Herrmann Consulting · Weiskirchen, Germany