The AI-Native ERP System for GxP Manufacturing
One platform for quality, documents, training, operations, compliance, and AI Modern regulated manufacturers are under constant pressure to improve quality, accelerate operations, maintain workforce readiness, and stay inspection-ready.
KOŚA brings every critical process together on a single validated platform, helping pharmaceutical, biotech, medical device, nutraceutical, CDMO, and laboratory organisations operate with confidence.
Trusted by training and quality leaders in pharma, biotech & medical devices
Built for regulated teams. Designed for operational excellence.
Most organisations manage compliance through a patchwork of disconnected systems, spreadsheets, shared drives, paper records, and manual processes.
KOŚA replaces fragmented tools with a unified platform that connects people, processes, documentation, training, and operations.
- Centralized quality, compliance, and operational workflows
- Audit-ready records with complete traceability and version control
- Built-in GxP compliance aligned with FDA, EMA, and global standards
- AI-powered insights to reduce risk and improve decision-making
Four Pillars. One Compliance Platform.
Everything regulated organizations need to manage quality, compliance, training, and operations, unified in a single GxP-ready platform.
Pillar I — Quality Excellence
Pillar II — Document Control
Pillar III — Workforce Readiness
Pillar IV — Operational Excellence
Train. Qualify. Stay Inspection-Ready.
Automated training assignments whenever SOPs change, CAPAs require retraining, or employees transition into new roles.
Eliminate compliance silos. Gain complete visibility.
Move beyond scattered documents, spreadsheets, emails, and disconnected software systems.
KOŚA brings your compliance ecosystem together in one audit-ready platform.
Built for regulated industries.
KOŚA supports organizations operating in highly regulated environments.
Pharmaceutical Manufacturing
Accelerate quality processes while maintaining complete compliance and inspection readiness.
Biotechnology
Support innovation with structured quality, training, and operational controls.
Medical Devices
Align with ISO 13485 requirements and global regulatory expectations.
Nutraceuticals
Improve quality consistency while maintaining operational efficiency.
CDMOs & CMOs
Standardize compliance processes across customers, facilities, and product lines.
Laboratories
Manage documentation, training, quality systems, and operational workflows from one platform.
Built for GxP. Validated for inspections.
KOŚA is an AI-driven pharmaceutical ERP designed to meet the regulatory, validation, and data integrity requirements of modern life sciences organizations. Every module is built with compliance by design, helping teams stay inspection-ready from day one.
21 CFR Part 11 Compliant
Electronic records, electronic signatures, and complete audit trails
EU Annex 11 Aligned
Validated computerized systems for regulated environments
ALCOA+ Data Integrity
Attributable, Legible, Contemporaneous, Original, Accurate - and more
GAMP 5 Validation Framework
Risk-based validation and computerized system assurance
WHO & Global Regulatory Alignment
Support for internationally recognized quality and compliance expectations
End-to-End GxP Compliance
Quality, documents, training, validation, and operations on one platform
Ready to modernize GxP operations?
Book a 30-minute session with a compliance architect.
Bring your toughest audit challenge – we’ll show you exactly where the evidence lives inside KOŚA and how quickly your team can access it.