Industry Thought Leaders
Guiding Innovation, Shaping Perspectives
Global Expertise
Navigating Complexity with Precision
10+ Years Experience
Your Reliable Partner Since Inception
Is non-compliance hindering your operations and business growth?
Don’t let non-compliance hinder your progress. At ValiTech Validation, we empower you to transform challenges into triumphs. Join us in creating a future where compliance is not a burden but a strategic advantage.
Why Choose Valitech?
Proven in front of regulators. Over the past two years, our documentation has been through 10+ EU GMP audits, 5+ PIC/S audits, and 1+ ANVISA inspections — all completed with minimal observations relating to CSV and IT compliance.
Built to current standards. Every engagement follows FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 — including cloud-hosted and SaaS systems, not just on-premise ones.
Risk-based, not padded. Validation effort is scaled to the risk a system genuinely poses to product quality and patient safety, so you pay for depth where it counts.
Validation and the IT beneath it. We qualify the infrastructure, write the IT SOPs, and validate the systems that run on them — one accountable vendor, one coherent record.
Our Services
Validation Excellence for Digital Systems
Expert validation services for ERP systems, laboratory instruments, process control systems, and more.
Regulatory Affairs Mastery
power of regulatory expertise with dossier preparation, submission services, and compliance advisory.
Temperature Mapping Precision
temperature mapping for critical storage environments. Identify risks, ensure uniformity.
21 CFR Part 11 Compliance Solutions
Our specialists conduct gap analysis, develop risk-based remediation plans, and guide your systems.
GxP IT Services
IT SOPs, infrastructure development and qualification, backup and restoration, testing and implementation.
