Core
DMS
Document Management
Controlled SOPs, change control, watermarked copies and full document lifecycle with role-based approvals.
Explore DMSThe 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
Platform architecture
One Platform. Three Connected Domains.
KOŚA brings every regulated function onto a single data layer, so information flows naturally between quality, documents, manufacturing and the lab.
Quality & Compliance
Proactive quality control, audits and validation in one closed-loop system.
QMSAuditValidationComplaints
Documents & Training
Controlled documents and role-based training connected to every process.
DMSLMS
Manufacturing & Operations
Digital batch execution, material flow and equipment records – ALCOA+ aligned.
E-BMRMaterial MgmtE-Log BookMaintenance
Laboratory & Intelligence
Sample-to-result lab workflows infused with AI search and trend analytics.
LIMSAI AssistAnalytics
Compliance framework
Compliance built into every workflow.
Instead of adapting generic software for regulated environments, KOŚA embeds compliance directly into operational processes - every action logged, attributable and inspection-ready.
REG · 01
21 CFR Part 11
Electronic records and electronic signatures.
REG · 02
EU Annex 11
Computerised system compliance.
REG · 03
ALCOA++
Enterprise-wide data integrity.
REG · 04
GAMP 5
Validation and CSA readiness.
REG · 05
WHO GMP
Global manufacturing standards.
The complete module library
Fourteen modules. Four categories.
Deploy what you need today; add the rest as your requirements evolve - all on the same unified data layer and audit trail.
Core
LMS
Learning Management
Role-based GxP training, OJT attestation with supervisor e-signature and live compliance dashboards.
Explore LMSCore
ACCESS & ROLES
User Management
Manage GxP users, roles, permissions and access controls with complete accountability and traceability.
Explore User ManagementCore
AD
Active Directory
Native AD / LDAP / SSO. Centralised user, role and access governance.
Explore ADQuality
QMS
Quality Management
Deviations, CAPAs, change control and risk - linked to documents, training and audits.
Explore QMSQuality
VLM
Validation Management
Full URS → FS → DS → IQ / OQ / PQ chain. GAMP 5 aligned packs with reusable templates.
Explore VLMQuality
A&C
Audit & Compliance
Internal audits, supplier audits and regulatory inspection management with finding workflows.
Explore A&CQuality
MC
Market Complaint
Capture, triage, investigate and trend complaints with full regulatory reportability.
Explore MCOperations
LIMS
Laboratory Info. Mgmt
Sample lifecycle, instrument integration, electronic worksheets and COA generation.
Explore LIMSOperations
MM
Material Management
Receipt, sampling, status control and dispensing - traceable from goods-in to finished product.
Explore MMOperations
E-BMR
Electronic Batch Records
Paperless batch execution with in-line e-signatures and exception management.
Explore E-BMROperations
E-Log
Electronic Log Book
Replace paper logbooks for equipment, areas and activities - fully ALCOA+ aligned.
Explore E-LogOperations
SMM
System & Maintenance
Calibration, preventive maintenance, downtime tracking and environmental monitoring.
Explore SMMAI
LLM
AI / LLM Assist
Semantic search across SOPs, complaint auto-triage and validation document drafting.
Explore LLMCapability deep-dive
The workflows that run regulated operations.
Every module shares the same data layer, the same audit trail and the same control framework - so nothing has to be reconciled between systems.
01 · DMS
Document Management System
Manage SOPs, protocols, specifications and controlled documents with version control, approvals and audit trails.
- Controlled document lifecycle with e-signatures
- Watermarked, role-based access to every copy
- Full audit trail - who read, changed and approved
02 · QMS
Quality Management System
Digitally manage CAPAs, deviations, risk assessments, change controls and investigations in one connected workflow.
- Deviation → investigation → CAPA in one thread
- Risk-based triage with configurable workflows
- Linked to documents, training and audits
03 · VLM
Validation Lifecycle Management
Execute URS, FS, DS, IQ, OQ and PQ activities through a structured GAMP 5 aligned workflow with reusable templates.
- Complete URS → PQ chain in a single system
- Reusable templates and requirement traceability
- CSA-ready evidence for computerised systems
04 · E-BMR
Electronic Batch Manufacturing Records
Replace paper-based batch records with digital execution, review-by-exception and electronic approvals.
- In-line e-signatures at every critical step
- Review-by-exception for faster batch release
- Full genealogy from raw material to finished good
AI-powered compliance assistance.
Accelerate compliance work without sacrificing traceability – every AI-assisted output is logged, attributable and reviewable like any other record.
SOP Search
Retrieve the exact clause, not the whole document.
CAPA Drafting
Structured first drafts from investigation notes.
Complaint Classification
Triage by severity and regulatory category.
Validation Docs
Draft URS / FS sections directly from requirements.
Knowledge Retrieval
Answers sourced and cited to controlled documents.
Compliance Insights
Surface drift before it becomes a finding.
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
Platform benefits
What changes with KOŚA.
Six concrete shifts customers see once quality, manufacturing and compliance run on the same unified platform.
01
Faster Audits
Find evidence in seconds.
02
Stronger Data Integrity
ALCOA+ controls built in.
03
Connected Operations
One source of truth.
04
Reduced Compliance Risk
Standardised workflows across sites.
05
Scalable Growth
Add modules as requirements evolve.
06
Continuous Readiness
Prepared for inspections year-round.
See KOŚA in action
Bring your toughest compliance challenge.
Discover how KOŚA helps pharmaceutical and life-sciences organisations streamline quality, manufacturing, validation and inspection readiness through a single AI-driven GxP platform.