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GxP · 21 CFR Part 11 · GAMP 5 · IP Protection · Audit
GxP21 CFR Part 11GAMP 5GDPRISO 27001EU Annex 11

Validated, GxP-compliant IT — audit-ready for pharma & life sciences

GxP-Compliant IT for the Pharmaceutical Industry

21 CFR Part 11, GxP compliance, highly secure data rooms, and IP protection for pharma and biotech companies.

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Industry-Specific Challenges

What makes IT particularly demanding for Pharma & Life Sciences

Computer System Validation

GxP-relevant systems must be validated per GAMP 5 and kept in a validated state.

21 CFR Part 11

Electronic records and signatures require audit trails and strict access control.

IP Protection

Research data is a high-value target — industrial espionage is a real threat.

Audit Readiness

Regulatory and customer audits can occur at any time — IT must be demonstrable at all times.

IT Consulting for Pharma & Life Sciences — no commitment

We know the requirements of your industry. In a free consultation we analyze your situation and show you concretely which solution makes sense for your business — with a binding offer within 5 business days.

Free GxP IT Assessment
GAMP 5-validated implementation
Audit-proof documentation
Wilmington · Delaware, USA