System validation · Pharma · Biotech · MedTech

Audit-secure on the systems your production runs on.

The systems your production runs on — LIMS, MES (PAS-X), Veeva Vault, SAP S/4HANA, MasterControl, eQMS — validated GxP-compliant, audit-secure, on budget.

01 Context

The systems that run your Pharma operations — need to hold under audit.

LIMS, MES, Veeva Vault and eQMS aren't generic enterprise tools — they're the digital backbone of GxP-regulated production, lab analytics and document control. Every batch record, every quality decision, every audit trail flows through one of these systems. When the validation slips, the operation slips with it.

Pharma-Operations-Software-Validation differs sharply from classic IT validation. ALCOA+ data integrity, batch-record review-by-exception, multi-tenant cloud audits, cross-system data flow MES ↔ SAP ↔ LIMS — these specifics decide whether the next FDA or EMA inspection is a stamp or a finding.

dhc has validated exactly this set of systems for 15+ years — across global Pharma, biotech start-ups and MedTech manufacturers. 60+ systems, 100% audit-pass, 0 findings on systems under our responsibility.

02 System-by-system

Six deep specialties — plus everything that runs in your GxP stack.

Same risk-based GAMP 5 spine, but each platform brings its own audit pitfalls. Here's how we approach the six big ones — followed by a compact overview of every platform we cover.

System 01 · LIMS

LIMS validation —
lab IT, GxP-compliant.

A LIMS doesn't just store sample data — it runs the analytical workflows your QC release decisions are built on. Validation has to cover the methods, the user-acceptance flow, and every interface to lab instruments. Drop one, and the audit-trail breaks.

01
LIMS
Laboratory Information Management
  • · Methoden-Validierung
  • · ALCOA+ Datenintegrität
  • · Geräte-Schnittstellen
System 02 · MES

MES & PAS-X —
validate production, not paperwork.

PAS-X (Körber/Werum) is the de-facto MES standard in Pharma production. The validation challenge isn't PAS-X itself — it's the interfaces. SAP for material flow, LIMS for analytical release, ERP for batch genealogy. We cover the whole loop.

02
MES · PAS-X
Manufacturing Execution
  • · Batch-Record-Review
  • · eMBR · Audit-Trail
  • · MES ↔ SAP ↔ LIMS
System 03 · Veeva Vault

Veeva Vault —
cloud validation done right.

Cloud heißt nicht „der Anbieter validiert das schon". Der Anbieter verantwortet die Plattform — den validierten Zustand Ihrer Konfiguration, Ihrer Daten und Ihrer Prozesse halten weiterhin Sie. Die Grenze zwischen Supplier-Audit und Kunden-Validierung ist gerade das teuerste Missverständnis in der Pharma-IT.

03
Veeva Vault
Cloud eQMS & eDMS
  • · Cloud-Audit-Logik
  • · Config vs. Customizing
  • · Release-Validierung
System 04 · SAP

SAP S/4HANA & EWM —
ERP-Backbone unter GxP.

SAP isn't an MES, but in Pharma operations it carries the material genealogy and the batch-genealogy that every GxP audit traces back to. The validation challenge sits where SAP touches the rest of the stack — and where roles and authorisations decide who can change a batch under audit.

04
SAP S/4HANA
+ EWM, MM, PP-PI
  • · Rollen & Berechtigungen
  • · Batch-Genealogie
  • · Audit-Trail im ERP-Core
System 05 · MasterControl & Cloud

MasterControl & cloud-native QMS —
validation under release pressure.

MasterControl, Vault QMS, AWS- and Azure-hosted GxP systems — all of them push regular vendor releases that can break your validated state silently. The right approach isn't to validate harder. It's to validate smarter: a regression framework that holds up across releases, and a clear vendor-audit boundary that doesn't let suppliers off the hook.

05
MasterControl · Cloud
QMS · AWS · Azure · Hybrid
  • · Vendor-Audit-Grenze
  • · Release-Regression
  • · Shared-Responsibility
System 06 · eQMS, eDMS & more

eQMS, eDMS & whatever else
runs in your GxP stack.

The four-block layout covers 80 % of what comes through. The other 20 %: LMS (training), CTMS (clinical trials), home-grown lab tools, regulated SaaS in clinical or pharmacovigilance. Same validation spine — different audit lens.

04
eQMS · eDMS
LMS · CTMS · Spezial-Systeme
  • · Plattform-neutral
  • · IVE-Standardansatz
  • · Hersteller-unabhängig
All supported platforms

The complete platform coverage at a glance.

Platform What we validate Audit focus
LIMS Methods, ALCOA+ data integrity, instrument interfaces QC release decisions
MES · PAS-X eMBR, review-by-exception, cross-system data flow Production audit trail
Veeva Vault Cloud config vs. customizing, release regression Document control & QMS
SAP S/4HANA · EWM Material genealogy, roles & SoD, EWM warehouse flows Quality release gate
MasterControl QMS modules, configuration-as-validation CAPA & Training
eQMS · eDMS Document control, change management, audit trail GxP documentation
Cloud & Hybrid Shared responsibility (AWS · Azure), hybrid stack Vendor audit boundary
CTMS Clinical trial management, site & patient flow GCP compliance
LMS Training records, GxP qualification logs Personnel qualification
Custom SaaS Bespoke regulated tools, in-house Excel/Python Risk-based scoping

Your platform not listed? Talk to us — the IVE methodology is platform-neutral.

03 Cross-system flow

The real risk isn't within a system —
it's between them.

Most audit findings we see today come from system boundaries: a batch number that drifts between MES and SAP, a sample ID that loses its audit trail when crossing into LIMS, a Veeva document version that no longer matches the GMP record. Data moves both ways — and so does the risk.

SAP
Material · genealogy
MES
Batch Record · eMBR
LIMS
Analytics · QC release
Veeva
eDMS · approval

We validate the boundaries the same way we validate the systems themselves: requirement-driven, risk-based, audit-trail-anchored. Each interface gets its own qualification scope, with mapped data fields, mapped error handling, and a documented test of what happens when one side fails. That last part — the failure test — is what most validation programmes skip, and what most auditors find first.

04 Track record

15+ years of validating exactly these systems.

Across four platforms, three regulators, one verifiable track record.

60+
Systems validated
LIMS · MES · Veeva · eQMS · weitere
15+
Years of practice
Pharma · Biotech · MedTech
100%
Audit pass rate
FDA · EMA · BfArM
0
Critical findings
On systems under our responsibility
05 FAQ

Common questions about system validation.

Can you take over a partly-validated LIMS migration?

Yes — and it's a recurring scenario. We come in, do a gap-analysis against your current validation state and the regulatory target, and pick up the migration without re-validating from scratch. Typical entry point: validation backlog from a previous consultant or in-house team that lost capacity.

How do you handle Veeva releases — three a year?

We build a regression framework once, with a defined test set against the configuration scope. On each Veeva release we run that framework — typically half a day of work, not a full revalidation. Critical changes (new modules, schema changes) get a delta-validation scope. Routine releases stay routine.

Do you validate interfaces between MES and SAP?

Yes — that's one of the highest-impact validation scopes we run. The MES↔SAP interface controls material movements, batch genealogy and release. A finding here can cascade across an entire site. We validate field-by-field, with explicit failure-mode tests.

Do you also handle method migration in LIMS?

Yes. Method migration is more analytics than IT — but the validation runs through the LIMS layer. We pair our CSV expertise with your analytical SMEs (often we work alongside your QC team's method experts) and run the cross-validation, the equivalence testing and the documentation.

What about platforms not on your list?

The four blocks cover what we see most. The IVE methodology is platform-neutral — same risk-based GAMP 5 spine, applied to whatever system runs your GxP stack. CTMS, LMS, regulated SaaS, in-house tools: talk to us, we'll tell you honestly whether we're the right fit.

Let's make your project
audit-proof.

Your project deserves a validation that accelerates go-live — not blocks it. Benefit from the assurance of 60+ successful projects.

60+
Projects
15+
Years
100 %
Audit-Pass
0
Findings
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