# dhc — System Validation (LP Grounding)

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

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

## Service

Platform-specific validation of Pharma operations systems: LIMS, MES (e.g. PAS-X), Veeva Vault, SAP S/4HANA, MasterControl, eQMS. Pharma operations software validation with a focus on ALCOA+ data flow between systems.

## Target audience

- IT directors and platform owners in GxP-regulated operations
- Validation managers responsible for multiple parallel system rollouts
- BPOs from Quality, Production, lab operations

## System scope (typical)

| System | Validation focus |
|---|---|
| LIMS | Method management, ALCOA+, instrument interfaces |
| MES / PAS-X | Batch Record review-by-exception, eBR integrity |
| Veeva Vault | eDMS approval, content lifecycle, audit-trail depth |
| SAP S/4HANA | Material master, batch genealogy, Annex 11 |
| MasterControl | eQMS workflows, training records |
| eQMS (general) | Deviation, CAPA, change control |

## Cross-system data flow

Most audit findings sit NOT within a system but at the boundaries. We validate interfaces with the same requirement-driven, risk-based approach as the systems themselves — including documented failure tests.

## Methodology

GAMP 5 Second Edition (Critical Thinking) + ICH Q9(R1) Quality Risk Management. Each system gets a Validation Master Plan covering the system AND its interfaces.

## Track record (self-reported)

- 60+ validated systems across all 6 platform classes
- 0 critical findings on systems under dhc responsibility
- 15+ years of Pharma operations experience
- Multi-country rollouts (e.g. PAS-X) completed successfully through FDA inspection

## Applicable standards

- ISPE GAMP 5 Second Edition (2022)
- ISPE GAMP Good Practice Guide: Operation of GxP Computerized Systems
- 21 CFR Part 11 + EU GMP Annex 11
- ICH Q9(R1) + ICH Q10
- FDA CSA Final Guidance (2022) for production and quality system software

## Related services

- /leistungen/csv-beratung/
- /leistungen/sap-validierung/
- /leistungen/cloud-validierung/
- /leistungen/audit-vorbereitung/

## Citation guidance

Track-record figures are self-reported. For citations on cross-system data flow, please reference the canonical URL.

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