The AI-Native ERP System for GxP Manufacturing

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.

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Trusted by training and quality leaders in pharma, biotech & medical devices

PharmaCorpBioGenexMediLabsCuraVitaNovaPharmBioTrust
Why KOŚA

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.
  • Drag-and-drop module and quiz builder
  • Centralized document library for SOPs & training materials
  • Version control across every learning asset
  • AI-assisted course drafting
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The KOŚA Platform

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

  • Deviations
  • CAPA Management
  • Audits & Inspections
  • Complaints Handling
  • Change Control
  • Risk Management
  • Supplier Quality

    • Pillar II — Document Control

  • SOP Management
  • Document Management
  • Version Control
  • Electronic Signatures
  • Controlled Distribution
  • Periodic Reviews
  • Approval Workflows

    • Pillar III — Workforce Readiness

  • Learning Management System (LMS)
  • Automated Training Assignments
  • Assessments & Quizzes
  • Competency Management
  • Training Qualification Tracking
  • Retraining Workflows

    • Pillar IV — Operational Excellence

  • Equipment Management
  • Calibration Management
  • Preventive Maintenance
  • Asset Tracking
  • Inventory Management
  • Facility Operations
  • Manufacturing Support Workflows
    • 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.
  • Training triggered by document revisions and CAPAs
  • Competency-based qualification management
  • Complete training histories and assessment records
  • Electronic signatures and audit-ready evidence
  • Real-time workforce compliance dashboards
    • Explore workforce readiness
    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.
  • One source of truth for documents, quality, and training
  • Automated compliance and approval workflows
  • Instant access to audit evidence and records
  • Real-time dashboards and compliance monitoring
  • AI-assisted search and regulatory insights
  • Faster inspections with inspection-ready records
  • Complete traceability from action to outcome
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    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.

    14 Integrated Modules
    100% Audit Traceability
    21 CFR Part 11 Ready
    GxP Compliance by Design
    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.

    Verified Compliant

    21 CFR Part 11

    Electronic records & signatures

    EU Annex 11

    Computerised systems in GxP

    ALCOA++ Principles

    Data integrity by design

    GAMP 5 Validation

    Risk-based validation lifecycle

    WHO Data Integrity

    Global data integrity guidance

    ICH Q8–Q10 Aligned

    Quality system alignment

    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.
    Book your session