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KOŚA is a quality management system software for pharmaceutical industry teams, connecting document control, change control, deviations, CAPA, audits, training, suppliers, and risk into a single configurable workflow engine. It’s the quality management system in pharmaceutical industry operations rely on to stay validated and audit-ready — a pharmaceutical QMS built for 21 CFR Part 11, EU GMP Annex 11, and ICH Q10 from day one. Whether you’re comparing your first pharmaceutical QMS software platform or replacing a legacy one, the workflow engine stays the same underneath.
Quality that holds up from raw material to release, and every inspection in between.
Trusted by quality & compliance teams in pharma, biotech & medical devices
PharmaCorp
BioGenex
MediLabs
CuraVita
NovaPharm
Pharmaceutical QMS
A pharmaceutical quality management system is the structured set of processes, documentation, and controls that ensures every batch, procedure, and decision meets regulatory and quality requirements. QMS in pharma spans the full product lifecycle, from raw material intake through manufacturing, testing, and distribution — and ties document control, CAPA, deviations, training, and audits into one accountable system. Done well, QMS in pharmaceutical industry operations becomes the backbone of every inspection, every batch release, and every management review. It’s also what separates a genuine pharmaceutical QMS from a folder of spreadsheets with a compliance label on it.
Compliance
GMP, GDocP, and ICH Q10 expectations are enforced inside the workflow itself, not reconciled afterwards at audit time.
Traceability
A single audit trail follows every deviation, change, and CAPA from origin to closure, nothing is hand-carried between systems.
Risk visibility
Overdue reviews, unassessed changes, and trending nonconformances are flagged while they are still cheap to fix.
Cross-functional alignment
A pharma quality management system only works if every function trusts it. Here’s how KOŚA aligns quality across the business:
Own the full quality event lifecycle end-to-end, from first detection to verified closure.
Keep submissions, correspondence, and change history under one version-controlled system.
Grant the shop floor access to only the current, effective procedure, without any additional information.
Standardise study, method, and validation documentation through every revision.
Walk into every management review, and every inspection already prepared.
Core processes
KOŚA QMS software for pharmaceutical industry teams is structured around the processes that matter most during an audit or inspection, from raw-material receipt through post-market surveillance.
Creation, review, approval, release & retirement of SOPs, protocols & specifications
Impact-assessed, risk-based routing for process, system & documentation changes
Investigation, classification & resolution of unplanned events
Root-cause analysis through to verified, closed corrective and preventive action
Planning, execution & follow-up for internal, external & supplier audits
Role-based training matrices linked automatically to controlled documents
Intake, investigation & regulatory-reportable complaint tracking
Qualification, quality agreements, scorecards & risk-based re-assessment
IQ/OQ/PQ, preventive maintenance & calibration scheduling
ICH Q9-aligned risk assessment, scoring & mitigation tracking
QC review, CoA generation & final disposition sign-off
Structured KPI, CAPA & risk review packs for leadership
Reporting & Analytics
As pharmaceutical QMS software, KOŚA exposes backlog, cycle time, and compliance metrics across sites on live dashboards, and produces audit-ready evidence for every review. This is the operational core that any quality management system in pharma needs to deliver — visibility without manual compilation, and evidence that’s ready before the auditor asks for it.
Regulatory frameworks
As a pharmaceutical quality management system, KOŚA helps you implement quality processes that maintain traceability, controlled access, and documented oversight across the entire product lifecycle.
Audit trails, access control & signature binding.
Finished pharmaceutical manufacturing controls.
Lifecycle model integrating GMP across the product journey.
Systematic identification, control & review of quality risk.
GMP-regulated manufacturing & quality activities.
Process approach, risk-based thinking & continual improvement.
Cross-authority manufacturing & inspection framework.
Risk-based validation, including IQ / OQ / PQ.
Implementation
A phased, low-risk rollout designed around your validation package and audit calendar, with structured quality support from the first day.
Week 1–2
Process inventory, regulatory gap analysis & structured migration plan.
Week 3–5
CAPA, deviation, change control & training workflows configured to your SOPs.
Week 6–8
User acceptance testing alongside your CSV package, ready for QA sign-off.
Week 9–10
Phased go-live with role-based training and ongoing quality support.
Get started
Book a 30-minute walkthrough with a compliance architect and see why quality teams are switching to KOŚA pharma quality management software — tailored to your SOPs, your risk profile, and your next audit.
21 CFR Part 11 · ICH Q10 · EU Annex 11 · GAMP 5 · ALCOA+
FAQs
Yes. KOŚA is built to support 21 CFR Part 11, EU GMP Annex 11, and ICH Q10 requirements from day one, with e-signatures, access controls, and an immutable audit trail included as core features, not add-ons configured after the fact. Your CSV package is built alongside UAT during implementation, so validation evidence is ready when QA needs to sign off.
