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

PharmaCorp

BioGenex

MediLabs

CuraVita

NovaPharm

BioTrust
FROM SILOS TO A SINGLE PLATFORM

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.

One platform. One source of truth. Complete traceability.

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

Workforce Readiness

Train. Qualify. Stay Inspection-Ready.

Connect training directly to documents, quality events, and employee roles to ensure continuous compliance across your organization.

Automated training assignments whenever SOPs change, CAPAs require retraining, or employees transition into new roles.

Why organizations choose KOŚA

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.

Industries we serve

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.

Compliance Assurance

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.