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For Life-Science Companies Ready to Leave Validation Bureaucracy Behind

The validation boutique you've been looking for — lean, audit-safe, and built for execution.

  • Cut your validation costs by up to 30% and timelines by 50% with our Lean CSVA System.
  • Build audit-ready systems that scale with your growth.
  • Complete validation projects without overloading your internal teams.
  • Empower your team with expert mentoring and CSA-aligned methods.
  • Gain senior-level validation leadership — without adding headcount.
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It’s not your fault. The industry made it this way.

But the cost of staying stuck are high. Missing deadlines, audit risks, and wasted resources.

Validation today is slow, overly bureaucratic, and disconnected from operational reality.
Blame decades of outdated compliance practices layered with every new regulation.

The old methods?
 They were built to drown teams in paperwork, not drive real outcomes.
 And the big consulting firms? They just kept piling on templates and checklists — keeping the system broken.

And while regulators introduced CSA and opened the door to leaner approaches,
 much of the industry stayed stuck, married to the bloated ways of the past.

Here’s the bottom line:

Legacy models don’t work
Over-documentation kills progress.
The status quo is no longer enough.

Validation, Reengineered for
Modern Life-Science Operations

Accelerated Execution

Up to 50% faster validation timelines — without quality trade-offs

Audit-Proven Outcomes

Every deliverable aligned with GAMP5 (2nd Ed.), CSA, GxP, FDA, and EU requirements.

Lean Governance & Methodology

Risk-based, scalable, and adaptable — ready for any system, any team.

Real Team Enablement

We coach, support, and equip your internal experts to own the process long-term.

Validation, Reengineered for
Modern Life-Science Operations

Lean CSVA System

Lean CSVA™ – The first ready-to-use validation system that combines speed with compliance, ensuring patient safety, product quality, and data integrity.
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Project Validation Execution (Done-for-You)

You Run the Business. We Run the Validation.
Full-service delivery of your CSV/CSA projects — with structure, speed, and compliance seamlessly built in

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Project Validation Coaching (Done-with-You)

Validation coaching designed for life-science teams ready to own the process — with confidence, clarity, and expert support at every step.
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Remote Validation Management Organization

Your Offshore Validation Team – Fully Remote. Fully Embedded. Our CSV/CSA experts manage your entire validation organization — remotely, reliably, and always audit-safe.
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Program Methodology for Large-Scale Rollouts

Structure Before Scale – Your Validation Backbone for Enterprise Programs. Create a lean, audit-ready validation methodology tailored for ERP, Veeva, QMS, LIMS, and other complex system transformations.
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Your Trusted Partner for Lean, Audit-Safe Validation.

Daniel Herrmann Consulting

We don’t just validate systems.

We build validation systems that drive speed, clarity, and control — across ERP, QMS, LIMS, and custom environments.

  • 60+ systems delivered in 8+ countries
  • Audit-tested, real-world frameworks trusted by Top 30 pharma and scale-ups alike
  • Specialists in CSV, CSA, lean compliance, and digital validation governance
  • German precision. Global execution.

Join the innovators transforming validation into a growth driver.

Schedule your strategy call today.

Client Success Stories

Mid-Sized Pharma Company – Global ERP Validation

Problem: Bloated, inconsistent processes delayed system rollout while increasing audit risks.

Result: Validation timelines reduced by 35%. ERP Go-Live on-time. Zero critical audit findings.

 “Daniel turned our biggest bottleneck into an operational win.”

Top-10 Pharma Company – GxP System Integration

Problem: Long validation delays and overwhelmed internal teams put critical system launches at risk.

Result: 20+ go-lives in 12 months. 40% reduction in internal CSV workload.

 “No one knows execution like Daniel Herrmann Consulting. Period.”

Mid-Sized Pharma Company – Global ERP Validation

Problem: Bloated, inconsistent processes delayed system rollout while increasing audit risks.

Result: Validation timelines reduced by 35%. ERP Go-Live on-time. Zero critical audit findings.

 “Daniel turned our biggest bottleneck into an operational win.”

*Testimonials have been anonymized to comply with data protection regulations.

Take Action

You already know what’s broken. We’re here to fix it.
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30% lower CSV costs — without losing control
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50% faster validation — without sacrificing compliance
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Zero chaos — just structured execution
Built to scale — from single systems to global rollouts
Modernize Your Validation Now.

We answer the tough questions upfront:

What makes the Lean CSVA system audit-safe?
Every element aligns with GxP, FDA, EMA, and CSA principles. Lean doesn’t mean cutting corners — it means cutting unnecessary waste.
Usually within 10–14 business days after onboarding.
On average, clients see 30–50% faster validation timelines and cost reductions of 30% or more — while improving operational clarity.
Absolutely. We refine what works, eliminate what doesn’t, and evolve your methods into lean, high-performance validation machines.

Still have questions? Let’s find the answers together. Book your call now.

Daniel Herrmann Unternehmensberatung
Saarlouiser Straße 95
66740 Saarlouis

Effiziente und praxisnahe Validierung computer-gestützter Systeme.

Top 30 Life-Science Unternehmen vertrauen mir.