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KOŚA is an AI-driven, GxP-compliant Enterprise Resource Planning (ERP) software platform, designed to deliver secure, transparent, and compliant operations across regulated life sciences environments.
Unlike traditional enterprise systems that are costly, complex, and difficult to validate, KOŚA delivers enterprise-grade compliance management, quality oversight, and regulatory readiness through a modern cloud-native platform.
Built for Global Compliance
Our solutions are designed to support the world’s most stringent regulatory requirements, helping life sciences organizations maintain compliance, ensure data integrity, and remain inspection-ready at every stage of operations.
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The Suites
A unified compliance ecosystem designed around ALCOA+, 21 CFR Part 11, and EU Annex 11 requirements.
Key Capabilities
Compliance Standards
Modern manufacturing operations built specifically for pharmaceutical production.
Key Capabilities
Compliance Standards
Brand Essence
Built for highly regulated environments where precision is non-negotiable.
Enterprise-grade capability at practical cost, leveling the playing field.
Structured systems meticulously designed for compliance integrity.
Cloud-native workflows built for operational scale and speed.
Results You Can Measure
KOŚA helps pharmaceutical organizations replace fragmented systems, manual compliance processes, and paper-based operations with a unified AI-driven, GxP-compliant platform. The result is faster execution, stronger compliance, and continuous inspection readiness.
Faster
Document retrieval during audits and inspections
Reduction
In manual compliance documentation effort
Faster
Training assignment and completion workflows
Reduction
In validation documentation review cycles
Improvement
In batch record traceability and visibility
Audit Trail
Across quality, manufacturing and compliance
Core Values
Compliance, transparency, and trust are never compromised.
Every workflow supports accuracy, consistency, and traceability.
Mission-critical systems engineered for regulated manufacturing.
Enterprise-grade compliance made attainable for every organization.
Modernizing compliance through AI-driven, intelligent workflows.
Purpose Built, Industry Specific
Unlike generic ERP systems, KOŚA is purpose-built for organizations operating under GxP regulations – helping teams maintain compliance, ensure data integrity, and accelerate operational excellence.
Regulated Operations
Bring a real SOP, a real audit finding, or your real training matrix. We’ll show you exactly how KOŚA handles it.
