Clouderio
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.

PartnerMicrosoft PartnerGoogle PartnerAWS PartnerIONOS Partner
GDPR Certified
NIS2 Compliant
US-Based LLC
<4h Response Time

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