The KOŚA Platform

Unified quality, manufacturing & compliance management for life sciences.

An AI-driven, GxP-compliant ERP platform that digitises quality, validation, training, laboratory, manufacturing and compliance workflows in a single audit-ready environment.

Compliance-ready by design

21 CFR Part 11

EU Annex 11

ALCOA+

GAMP 5

WHO GMP

Quality & Compliance

Proactive quality control, audits and validation in one closed-loop system.

Manufacturing & Operations

Digital batch execution, material flow and equipment records – ALCOA+ aligned.

Laboratory & Intelligence

Sample-to-result lab workflows infused with AI search and trend analytics.

01 · DMS

Document Management System

Manage SOPs, protocols, specifications and controlled documents with version control, approvals and audit trails.

02 · QMS

Quality Management System

Digitally manage CAPAs, deviations, risk assessments, change controls and investigations in one connected workflow.

03 · VLM

Validation Lifecycle Management

Execute URS, FS, DS, IQ, OQ and PQ activities through a structured GAMP 5 aligned workflow with reusable templates.

04 · E-BMR

Electronic Batch Manufacturing Records

Replace paper-based batch records with digital execution, review-by-exception and electronic approvals.

AI-powered compliance assistance.

Accelerate compliance work without sacrificing traceability – every AI-assisted output is logged, attributable and reviewable like any other record.

Inspection Readiness

Always ready for inspection.

When regulators request evidence, retrieve records instantly — not after a week of pulling files together.

Audit Trails

Electronic Signatures

Version Control

Role-Based Access

Training Evidence

Batch Traceability

Validation Records

Automated Reports