Quality & Compliance
Inspection-ready, every day
Run FDA, EMA and CDSCO inspections from one tamper-proof audit trail — no scrambling for evidence.
KOŚA for Pharmaceutical Manufacturers
Unify Quality, Training & Batch Records.Pass your next inspection — in 90 days.
The modern compliance OS for mid-market pharma stuck between expensive legacy contracts and risky Excel + SharePoint workflows. Enterprise-grade controls. KOŚA pricing.
Why pharma teams choose KOŚA
Built for the people who own GxP.
One platform that aligns Quality, Manufacturing and IT — without the cost or implementation risk of legacy enterprise suites.
Manufacturing & Ops
Move batches, not paper
Replace logbooks and Excel with electronic batch records, e-signatures and exception workflows.
IT & Validation
GAMP 5 built in, not bolted on
Reusable URS → IQ/OQ/PQ packs, validated change control and SSO into your existing AD.
90 days
From kick-off to first audit-ready site
40%
Lower TCO vs. legacy enterprise suites
2,000+
Concurrent users without degradation
99.9%
Uptime SLA with Multi-AZ failover
Connected modules
See all 13 modules →One platform for every GxP workflow.
Start with DMS + LMS. Layer in QMS, LIMS, E-BMR and Material Management as you grow — all on the same audit-ready stack with shared users, training records and audit trails.
Document Management (DMS)
Controlled SOPs with change control, watermarked copies and role-based approvals.
Learning Management (LMS)
Role-based GxP training and OJT attestation with supervisor e-signature across sites.
Quality Management (QMS)
Deviations, CAPAs, change control and risk — linked to docs, training and audits.
Electronic Batch Records (E-BMR)
Paperless batch execution with in-line e-signatures and exception management.
LIMS
Sample lifecycle, instrument integration, electronic worksheets and COA generation.
Material Management
Receipt, sampling, status control and dispensing — traceable from goods-in to release.
Outcomes
What changes the day you go live.
KOŚA replaces a patchwork of paper, SharePoint and legacy on-prem systems with one modern, validated platform — designed by compliance architects who’ve passed FDA audits.
90-day deployment guarantee
DMS + LMS live, validated and inspection-ready in one quarter — backed in writing.
Compliance by design
Engineered to be audited — not just to comply.
Every action signed, timestamped and immutable. Every record ALCOA++ aligned. Every release backed by a validated change control trail.
21 CFR Part 11
EU Annex 11
ALCOA++
GAMP 5
WHO Data Integrity
ICH Q8–Q10
"We went from three disconnected systems and a paper logbook nightmare to one inspection-ready platform in under 90 days. Our last audit closed with zero 483 observations."
Head of Quality, Tier-2 Indian pharma manufacturer
See KOŚA running on your SOPs.
45-minute demo with a compliance architect — no slideware, no sales pitch.