Validation that accelerates — not blocks
Risk-based by patient and business impact. Results from week 1 — without compliance compromise.
For project and IT leaders
Computer System Validation for Pharma, Biotech & MedTech.
Your Go-Live.
On time. On budget.
No findings.
On time. On budget.
No findings.
100% audit-proof — and still the fastest way to go-live. Backed by 60+ projects and 15+ years of practice.
GxP compliance consulting helps your team implement the applicable requirements for computerised systems in Pharma, Biotech and MedTech — such as EU GMP Annex 11 and, where applicable, 21 CFR Part 11. GAMP 5 serves as the recognised good-practice framework for risk-based validation. You get consulting and execution from the same senior team: Computer System Validation, SAP and cloud validation, audit readiness and AI system validation.
Evidenced across 15+ years: 60+ validated systems, 100% audit pass rate, 0 critical findings.
01 Why us
Four differentiators that pass every audit.
Classical CSV frameworks slow projects down. We think differently — risk-based, integrated, outcome-focused.
Risk-based prioritisation
Only what truly matters — by patient risk and business impact. Up to 30% less documentation effort.
Immediate relief
Clear ownership from day 1. No alibi workshops — direct impact in the project team and at audit time.
60+ systems, 0 findings
Verifiable. 100% audit pass rate across 15 years and global rollouts.
60+
Systems validated
15+
Years experience
100%
Audit pass rate
0
Critical findings
02 From 15 years of practice
Why classical CSV frameworks hit their limits today.
Risk
Checklist-based prioritisation — not risk-based
The traditional approach treats every system the same. A modern, risk-based framework focuses energy where it has the greatest patient and business impact.
Structure
Sequential sign-off models from the pre-agile era
Classical role architectures were built for sequential waterfall projects. Modern cross-stream projects need clear decision structures with defined owners from day 1.
Efficiency
Documentation standards from another era
Many CSV templates were designed before CSA guidance. Today, a risk-based approach allows leaner, focused evidence — without compliance compromises.
Knowledge
SOPs are stable — regulatory expectations evolve
Your team has a solid formal foundation. For the next step, update paths to GAMP 5 2nd Edition and CSA help to bring practice back in sync with theory.
Communication
Cross-stream coordination gets complex
Business, IT and QA each have their own language — that's normal. A shared, methodically integrated way of working gets everyone on the same plan.
Control
Classical reports show output — not the real project pulse
What used to count as progress isn't enough for today's timelines. Modern steering dashboards make compliance status visible in real time.
The next step isn't a fresh start — it's an update. A structured, risk-based approach brings your framework to where modern projects need it.
03 Our approach
IVE — Integrated Validation Execution.
Because concepts alone don't take systems live.
I
For: Business owners & IT leadership
Synchronisation, not silos
In complex projects, success often fails at the interfaces. We integrate validation seamlessly into your existing business processes and frameworks — instead of building isolated processes.
Less friction, a relieved team, and a system that works in practice — without bureaucratic blockades.
V
For: CSV & Quality Assurance
The regulatory shield
Safety is not a negotiation — it is the foundation on which successful projects build. Methodically grounded validation per GAMP 5 2nd Edition, ISPE Good Practice Guides and FDA-CSA.
Regulatory backing with a verifiable track record across 60+ projects. 100% audit-proof — face every inspection calmly.
E
For: Project leads & System Owners
The engine of your delivery
Concepts alone don't take systems live. We combine validation management with project steering — test management, data migration, training and cut-over in one synchronised flow.
Results from week 1, strict budget discipline. No parallel worlds — one team, one goal: your go-live.
All services
Choose the entry point that matches your situation.
- CSV consulting Computer System Validation with the IVE methodology — GAMP 5, Annex 11, 21 CFR Part 11.
- GAMP 5 compliance GAMP 5 Second Edition, Annex 11, 21 CFR Part 11 + FDA CSA — risk-based audit strategy.
- System validation LIMS, MES (PAS-X), Veeva Vault, MasterControl, eQMS — the systems your production runs on.
- SAP validation S/4HANA migrations without findings — Greenfield, Brownfield, Bluefield and the audit pitfalls of each path.
- Cloud & SaaS validation Vendor-audit boundary, release-regression framework, hybrid-stack coverage.
- Audit readiness FDA, EMA, BfArM, Swissmedic — pre-inspection walkthrough, mock audit, on-demand team.
- AI system validation AI consulting, implementation support and validation for a defined GxP use.
- GxP system decommissioning Retire validated legacy systems — including data, metadata, archive, migration and closure evidence.
04 Enterprise & Global Rollouts
SAP & ERP rollouts for Pharma, Biotech & MedTech —
our specialty.
An SAP S/4HANA rollout in Life Sciences is not a simple validation — it is open-heart surgery. Global programs belong in experienced hands with a verifiable track record.
01 / Program architecture
Governance & program steering
End the ‘QA vs. PMO’ standoff. Validation is integrated seamlessly into your program governance. One language, one plan — zero friction between business and compliance.
02 / Template & localisation
Global template, local speed
A strong core template for consistency — smart local adaptation for adoption. Your rollout is industrialised across borders without losing the local nuances.
03 / Cutover & go-live
Cutover precision
The weekend of truth — and nothing left to chance. Military-grade planning across data migration, system switch and hypercare. So production runs Monday morning.
Supported systems
Validated on the leading platforms.
05 Results
The results speak louder
than we ever could.
Markus Schwarz
Project Manager – Transformation Program
Boehringer Ingelheim
Boehringer Ingelheim
Daniel showed tireless commitment to the project — especially in periods of high workload. Highly motivated to set priorities and ensure successful delivery. It was a pleasure to have him on the team — I recommend him without reservation.
Elisabeth Kohm
Head of QM & QA
HMS Analytical Software
HMS Analytical Software
From baseline analysis through project management and effort estimation to delivery and staff training — every task delivered competently and on time. Daniel kept company-specific characteristics in mind and scaled processes accordingly.
Patryk Rutkowski
Tollgate Review Lead
Novartis
Novartis
A global, multinational ERP implementation with tight deadlines and demanding stakeholders. Daniel led our team and showed himself highly skilled at turning a group of individuals into a cooperative, supportive and highly successful team.
More voices
Tireless commitment, even at peak load. Highly recommend.
Markus Schwarz
Project Manager · Boehringer Ingelheim
Competent, on time, scaled to our context. From baseline to training.
Elisabeth Kohm
Head of QM & QA · HMS
Turned a tough multinational ERP team into a high-performing one.
Patryk Rutkowski
Tollgate Review Lead · Novartis
A guarantor of success and outstanding performance in highly regulated projects.
Andreas Etges
Business Project Leader · Boehringer Ingelheim
Daniel delivers the highest value through his expertise and commitment in validation and compliance.
Jens Fuellbier
Head of GBS Governance · Boehringer Ingelheim
Daniel turns complex challenges into clear, practical solutions and inspires the highest quality.
Michiel Wannet
Senior Principal · Infosys Consulting
A patient expert who goes beyond expectations and brings even the most complex projects to a successful close.
Heidelinde Hecher
Quality Operation Specialist · Boehringer Ingelheim
A committed team player who brings every project to success with deep knowledge and expertise.
Boris Skoflic
Senior Consultant
An excellent validation manager with comprehensive GxP knowledge and a positive, supportive attitude.
Maywand Atrafi
Director · Envocon B.V.
A validation leader who convinces through passion and outstanding expertise and meets the highest standards.
Tony Baker
CFO · Takeda
06 Team
The people behind your project success.
Experienced CSV specialists for Pharma, Biotech & MedTech. No external silo — an integrated team at your side.
Daniel Herrmann
Dr. Philipp Cavelius
Jacqueline Schmitt
Caroline Herrmann
Tina Gosewinkel
Annette Mumber
Nala
07 How we work
Best practices from 15+ years of CSV practice — risk-based per GAMP 5.
Four phases. Clear owners. Results from day one — risk-based, audit-proof, on-budget.
01
Risk diagnosis
No alibi workshops. We analyse your setup, identify the critical systems and know within days where the focus belongs — and where it doesn't.
02
Risk-based plan
Prioritised by patient risk and business impact. Rigorously risk-based per GAMP 5. No ballast.
03
Execution & steering
We run validation operationally — testing, documenting, steering. Integrated into your project team, not an external silo. Results from week 1.
04
Go-live & enablement
Your system goes live on time. Your team is able to validate independently from there. No permanent dependency — that's the standard.
Risk-based prioritisation
Validation effort calibrated to actual risk — not checklist logic. Up to 30% less documentation work, without compliance compromises.
Results from day 1
No months-long concept paper. Structured diagnosis, clear plan, immediate execution. You see in the first week where the project is heading.
Audit-secure and verifiable
What the industry celebrates today as CSA has been lived practice for us for 15+ years. We didn't adopt the risk-based approach because it's trendy — but because it works.
We don't build dependencies.
We build teams.
Our engagement ends with your go-live.
Your team validates independently from there.
08 Strategic positioning
CSV is mandatory. We turn it into
a competitive advantage.
While others burn time and budget on validation, successful Life-Sciences organisations use it as a strategic lever — for faster go-lives, calmer audits, scalable growth.
Audit-Proof
Safety is the foundation
No compromises. Your system isn't just compliant — it's unassailable. Gap-free evidence that convinces auditors — stress-free and grounded.
Speed
Speed wins market share
Validation must not slow your timeline. Through structured risk focus and rigorous reuse of existing evidence, time-to-go-live is cut in half.
ROI
Focus drives growth
Less documentation effort, more focus on what matters. Good validation isn't a cost block — it's your insurance for scalable growth.
09 Blog
Grounded knowledge from
15 years of CSV practice.
No buzzword posts. Practical articles for project leads, IT and QA teams — straight from live validation projects.
Position Paper
How to Select CSV Consulting Services: A Buyer’s Guide
Select CSV consulting services by assessing delivery scope, seniority, governance, quality gates and knowledge transfer for life sciences.
Regulatory Update
Validating Electronic Batch Records: Control Vendor Changes
Electronic batch record validation: connect vendor access, audit trails, change control and batch decisions into inspection-ready evidence.
Position Paper
Cloud Validation: Make Shared Responsibility Audit-Ready
Cloud validation for Pharma: connect responsibility boundaries, supplier evidence, releases and customer controls into audit-ready evidence.
10 FAQ
Common questions about
our CSV consulting — answered honestly.
Remote or on-site? How do you integrate with my team?
We work wherever it's needed for project success. Workshops and critical phases we're happy to attend on-site. Operational work we deliver highly efficiently remote — easier on your budget, faster from our side. Thanks to modern tooling, we're often more present than the colleague in the next office.
Is your pragmatic approach truly 100% FDA- and EU-compliant?
Our risk-based approach follows GAMP 5 and, where the direct scope applies, the revised final FDA CSA guidance issued in February 2026 for medical-device production and quality management system software. We have applied risk-based validation consistently for 15+ years.
Do you create a dependency, or upskill my team?
Our goal is to make ourselves redundant. We don't validate in a silo — we bring your team along. At go-live we hand over not just a system, but the know-how to operate it compliantly over time. We want to be mentors, not permanent guests.
How quickly can we get started?
Within 2 weeks when needed. In the 30-minute strategy call we clarify your setup, scope and timeline. If we're the right partner, a concrete proposal arrives within 5 business days. If not, we'll tell you honestly and refer you onward.
Which systems do you have experience with?
SAP S/4HANA, EWM, Veeva Vault, MasterControl, LIMS systems, MES platforms, Custom SaaS and cloud systems. 60+ systems in 15+ years — in DACH and globally, from mid-size to top-10 pharma.
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
Free initial assessment · Focus on your project, not slides