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Built for Life-Science

Ready for Execution.

Lean IT-Compliance – The first ready-to-use validation system that combines speed with compliance, ensuring patient safety, product quality, and data integrity.

  • Reduce CSV and operational workload by up to 70%
  • Accelerate go-lives with built-in audit readiness
  • Eliminate unnecessary documentation — without risking compliance
  • Fully aligned with CSA, GxP, FDA, and EMA standards
  • Empower your team or let us lead the way

Stop wasting time on bloated compliance.

Book your Lean IT-Compliance session today.

Validation today isn’t broken. It was built that way.

Let’s be real. Most life-science companies still follow bloated CSV methods and overengineered operational IT-processes created for a different era: endless templates, useless documents, delayed go-lives, and teams burning time on compliance theatre.
You’re expected to move faster, stay lean, and scale — all while meeting tougher regulatory expectations. Yes, regulators introduced CSA. But most consultants keep selling old CSV and overengineered IT processes, wrapped in new buzzwords.

Here’s the truth

Legacy validation wastes time and money.
Over-documentation doesn’t protect you — it slows you down.
CSA alone won’t fix broken execution models.

You don’t need more templates.
 You need a smarter system.
 You need Lean IT-Compliance.

Validation. Rebuilt for Speed.
Built for Audits. Delivered as a System.

Execute 2× Faster

Start immediately with pre-built, ready-to-run validation processes — no reinvention, no delays.

Built-In Compliance

All templates, SOPs, and workflows are aligned with FDA CSA, GAMP5 (2nd Ed.), GxP, and Annex 11.

Operational Power

Change control, periodic reviews, incidents, testing — all pre-modeled and ready to deploy.

Enable Your Team

Training and onboarding included. Your team will know what to do, how to do it, and why it’s audit-safe.

Our Core Features

Ready-to-Use Validation Templates

Audit-tested, real-world documentation focused on risk-based, CSA-aligned execution.

CSA-Driven
Process Models

Lean workflows and logic trees for requirements, testing, risk classification, and more.

Full Lifecycle SOPs

Covering all critical operations — change control, incidents, reviews, access, and handover.

Turnkey Governance Structure

Built-in governance logic, review gates, and decision frameworks.

Training & Enablement

Coaching for your validation team with playbooks, examples, and expert sessions.

Optional Execution Support

Want us to run the show? Our senior experts can guide, lead, or collaborate alongside your team.

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.

Book your free call today.

Client Success Stories

Biotech Scale-Up – eQMS Validation

Problem: Overwhelmed QA team, no CSA strategy, FDA concerns.

Result: Full Lean IT-Compliance implementation. eQMS live in 10 weeks. Zero findings.

“We didn’t just pass the audit. We set a new standard.”

Top-10 Pharma – ERP Go-Live Rescue

Problem: CSV overkill, failed timelines, internal burnout.

Result: Timeline cut by 40%. ERP live on time. Zero findings during EU inspection.

“Daniel’s team delivered what three vendors couldn’t.”

MedTech Mid-Sizer – Validation Program Rebuild

Problem: Disjointed methods across sites; failed ISO audit.

Result: Lean IT-Compliance deployed globally. 25% faster validation timelines.

“We now have a validation model that scales — not one that breaks under pressure.”

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

Take Action

You already know what’s broken. We’re here to fix it.
30% lower CSV costs — without losing control
50% faster validation — without sacrificing compliance
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 IT-Compliance 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 Consulting
Saarlouiser Straße 95
66740 Saarlouis