Every entry is signed, timestamped, and cannot be quietly changed.
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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
KOŚA brings every regulated function onto a single data layer, so information flows naturally between quality, documents, manufacturing and the lab.
Proactive quality control, audits and validation in one closed-loop system.
QMS
Audit
Validation
Complaints
Controlled documents and role-based training connected to every process.
DMS
LMS
Digital batch execution, material flow and equipment records – ALCOA+ aligned.
E-BMR
Material Mgmt
E-Log Book
Maintenance
Compliance framework
Instead of adapting generic software for regulated environments, KOŚA embeds compliance directly into operational processes – every action logged, attributable and inspection-ready.
REG · 01
Electronic records and electronic signatures.
REG · 02
Computerised system compliance.
REG · 03
Enterprise-wide data integrity
REG · 04
Validation and CSA readiness.
REG · 05
Global manufacturing standards.
The complete module library
Deploy what you need today; add the rest as your requirements evolve – all on the same unified data layer and audit trail.
Available
DMS
Every entry is signed, timestamped, and cannot be quietly changed.
Available
LMS
Role-based GxP training, OJT attestation with supervisor e-signature and live compliance dashboards.
Available
AD
Native AD / LDAP / SSO. Centralised user, role and access governance.
Coming Soon
QMS
Deviations, CAPAs, change control and risk – linked to documents, training and audits.
Coming Soon
VMS
Full URS → FS → DS → IQ / OQ / PQ chain. GAMP 5 aligned packs with reusable templates.
Coming Soon
A&C
Internal audits, supplier audits and regulatory inspection management with finding workflows.
Coming Soon
MC
Capture, triage, investigate and trend complaints with full regulatory reportability.
Coming Soon
MM
Receipt, sampling, status control and dispensing – traceable from goods-in to finished product.
Coming Soon
E-BMR
Paperless batch execution with in-line e-signatures and exception management.
Coming Soon
E-LOG
Replace paper logbooks for equipment, areas and activities – fully ALCOA+ aligned.
Capability deep-dive
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
Manage SOPs, protocols, specifications and controlled documents with version control, approvals and audit trails.
02 · QMS
Digitally manage CAPAs, deviations, risk assessments, change controls and investigations in one connected workflow.
03 · VLM
Execute URS, FS, DS, IQ, OQ and PQ activities through a structured GAMP 5 aligned workflow with reusable templates.
04 · E-BMR
Replace paper-based batch records with digital execution, review-by-exception and electronic approvals.
Retrieve the exact clause, not the whole document.
Structured first drafts from investigation notes.
Triage by severity and regulatory category.
Draft URS / FS sections directly from requirements.
Answers sourced and cited to controlled documents.
Surface drift before it becomes a finding.
Inspection Readiness
Audit Trails
Electronic Signatures
Version Control
Role-Based Access
Training Evidence
Batch Traceability
Validation Records
Automated Reports
01
Find evidence in seconds.
02
ALCOA+ controls built in.
03
One source of truth.
04
Standardised workflows across sites.
05
Add modules as requirements evolve.
06
Prepared for inspections year-round.
See KOŚA in action
Discover how KOŚA helps pharmaceutical and life-sciences organisations streamline quality, manufacturing, validation and inspection readiness through a single AI-driven GxP platform.