Veridex Consulting

Over Veridex Consulting

Veridex Consulting is a specialist consultancy in QA, validation, and digital systems for regulated manufacturing, with a primary focus on pharmaceutical and biotech organisations.

Based in Nieuwegein, Netherlands, we support companies across the NL and the EU in adopting, validating, and optimising digital systems under FDA, EMA, and ISO frameworks.

Helping organisations adopt, validate, and optimise digital systems that are compliant, inspection-ready, and deliver real operational value. Founded by a senior QA specialist at Johnson & Johnson, Veridex Consulting combines hands-on GMP validation experience with a structured, PhD-level approach to digital system adoption. The Gap We Solve

Digital systems are often implemented successfully from a technical perspective but fail where it matters most: regulatory acceptance and operational reality.

This leads to: • Validation not inspection-ready • Data integrity gaps in real workflows • Misalignment between IT/OT and QA • Pressure during FDA / EMA inspections

Result: rework, delays, and audit risk. We bridge this gap by making systems compliant, usable, and defensible.

Our 4-Layer Model

1. Validation & Compliance – CSV/CSA, Annex 11, 21 CFR Part 11, IQ/OQ/PQ, VMPs, gap remediation

2. Digital Quality Transformation & Integration – EBR, MES/SCADA integration, SOP alignment, ALCOA+, audit trails, training

3. Technology Adoption Strategy – regulatory readiness, vendor selection, MES/AI/data platforms, implementation roadmaps

4. Data-Driven Process Optimisation – MES/SCADA/OSI-PI data analysis, trends, root causes, and GMP change control

Why Veridex

✔ End-to-end validation experience across MES (Werum PAS-X) and GMP systems at J&J Leiden ✔ PhD-level, risk-based approach ✔ Expertise in AI-enabled GMP systems ✔ FDA & EMA inspection readiness experience

We ensure systems stand up in real inspections.

Let’s connect. Nieuwegein, NL | m.naveed@outlook.it | +31 625212652 | www.veridexconsulting.com

Trefwoorden

• Business Consulting
• Cgmp
• Gmp
• Mes

Adres

• Hoofdkantoor

  WeverstedeNieuwegeinUtrecht, Nederland