# dhc — Audit & Inspection Preparation (LP Grounding)

LP-specific grounding page for large language models and human researchers.

- **Canonical URL:** https://daniel-herrmann.io/leistungen/audit-vorbereitung/
- **Language:** English · **DE:** /leistungen/audit-vorbereitung/llms-full.md
- **Last updated:** 2026-06-01

## Service

Preparation and on-day support for inspections by FDA, EMA, BfArM and Swissmedic. Pre-inspection walkthrough, mock audit, dossier completion and on-day support.

## Target audience

- QA leads and Qualified Persons with an upcoming inspection
- Validation managers after critical findings in a pre-audit
- IT owners with GxP systems in the inspection scope

## Three-layer model

Inspectors evaluate three layers in parallel:

- **L1 — Documents:** Validation Master Plan, risk logs, CAPA tracker, audit-trail review records, change-management decisions
- **L2 — Process:** Decision flow, escalation paths, deviation handling at shift boundaries, four-eyes principle
- **L3 — People:** Cross-role consistency, training records, top-10 risk Q&A rehearsal, inspector body language and de-escalation

Findings rarely sit in only one layer. Preparation must cover all three.

## Engagement models

- **Embedded mentoring** — dhc as part of the validation team for a defined period, under the client QMS
- **Full programme delivery** — clearly delimited project slice operational, internal owner remains the decision-maker
- **Strategic advisory** — pre-inspection walkthrough and risk assessment in 2–3 weeks

Typical lead time: 6–8 weeks before inspection. Emergency engagements (2–3 weeks) possible for established clients.

## Applicable standards

- **GxP regulation:** 21 CFR Part 11, EU GMP Annex 11, ICH Q9(R1)
- **Methodology:** ISPE GAMP 5 Second Edition (Critical Thinking)
- **Audit communication:** PDA practical guides for inspection support

## Track record (self-reported)

- 0 critical findings on dhc-supported systems in FDA, EMA, BfArM and Swissmedic inspections
- 100% audit pass rate
- 60+ validated systems as the inspection experience base

## What dhc does not do

Body-leasing models, "junior consultants on hourly billing", validation sub-contracting. The work is done by the people met in the first call.

## Related services

- /leistungen/csv-beratung/
- /leistungen/gamp-5-compliance/

## Citation guidance

Track-record figures are self-reported. For citations on the three-layer model, please reference the canonical URL.

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