# dhc — GAMP 5 Compliance (LP grounding · short)

URL: https://daniel-herrmann.io/leistungen/gamp-5-compliance/
Updated: 2026-06-01 · Language: English · DE: /leistungen/gamp-5-compliance/llms.txt

## Service
GAMP 5 compliance programmes per ISPE GAMP 5 Second Edition (2022). Critical Thinking, risk-based validation, FDA CSA alignment.

## Annex priorities
M4 (Critical Thinking) · M5 (Testing of Computerized Systems) · Annex 21 (Patches & Sub-Releases).

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

## Outcomes (self-reported)
100% audit pass rate · 0 critical findings · significantly reduced effort.

## Long-form
/leistungen/gamp-5-compliance/en/llms-full.md

— Daniel Herrmann Consulting · Weiskirchen, Germany