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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-proof 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 pharmaceutical and biotech companies.

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NIS2-compliant
Servers in Germany
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Industry-specific challenges

What makes IT especially demanding in Pharma & Life Sciences

Computer system validation

GxP-relevant systems must be validated according to 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 attack target — industrial espionage is real.

Audit readiness

Regulatory and customer audits can come at any time — IT must be able to provide evidence at any time.

IT consulting for Pharma & Life Sciences — no obligation

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

Free GxP IT status assessment
GAMP 5-validated implementation
Audit-proof documentation
Bad Homburg vor der Höhe · Rhine-Main Region