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  • KOŚA QMS · BUILT FOR LIFE SCIENCES

Quality Management System for Pharma.

Fewer open CAPAs.
More confidence at every inspection.

Bring deviations, CAPA, change control and audits into one connected, validated system — so every quality event has an owner, a deadline and a traceable outcome.

  • Deviation, CAPA & change control in one workflow
  • Electronic signatures & time-stamped audit trails
  • Live dashboards for overdue and high-risk events

A live walkthrough built around your process. We reply within one business day.

YOUR QUALITY PROCESS. CONNECTED.

See KOŚA QMS in action.

A tailored walkthrough for your quality events and inspection needs.

 

30-minute walkthrough · No obligation

Your details are used only to arrange your demo.

 

Trusted by quality, regulatory & IT teams in pharma, biotech & medical devices

 

PharmaCorp

BioGenex

MediLabs

CuraVita

NovaPharm

BioTrust

DESIGNED TO SUPPORT

  • 21 CFR Part 11
  • EU GMP Annex 11
  • ICH Q10
  • ISO 9001 / 13485

FROM SPREADSHEETS TO A CONNECTED QMS

Every quality event tracked.
Nothing lost between emails.

Replace disconnected logs and manual follow-ups with quality workflows that link events, root causes, actions and evidence.

 

Deviations captured at the source

Log, classify and investigate deviations with risk scoring and clear ownership.

CAPA that actually closes

Link root cause to corrective and preventive actions, with effectiveness checks and due-date alerts.

Change control with impact assessment

Assess impact across documents, equipment and training before changes go live.

Quality metrics in real time

See open, overdue and recurring events across sites for management review.

 

40%

of the cost of legacy compliance suites

14

modules on one validated platform

 

8-10

weeks typical KOŚA implementation

 

30 min

focused walkthrough, no obligation

 

EVERY EVENT. A CLEAR WAY FORWARD.

Find the root cause.
Close the loop.

1
Record the event
Capture deviations, complaints or audit findings with the right context.
2
Investigate & assess risk
Run structured root-cause analysis and prioritise by risk.
3
Act & approve
Assign CAPA or change actions, with e-signature approvals.
4
Verify & stay audit-ready
Check effectiveness and keep a complete, traceable record.
See the workflow in action

Walk through a deviation to CAPA

Follow a quality event from capture to investigation, action and closure.

Explore your compliance requirements

See how signatures, audit trails and access controls support inspections.

Discuss your rollout

Review migration, configuration, validation and implementation timelines.

YOUR DEMO, BUILT AROUND YOUR TEAM

Bring your process.
See how it fits.

For QA, QC, regulatory and site leadership teams evaluating a pharmaceutical QMS.

 

MAKE DOCUMENT CONTROL YOUR NEXT STEP

See KOŚA QMS in your environment.

One focused walkthrough. Your workflows, systems and compliance priorities.

Book my QMS demo

BEFORE YOU BOOK

A few common questions.

Which quality processes does KOŚA QMS cover?
Deviations, CAPA, change control, internal and supplier audits, market complaints and management review — connected in one system.

 

KOŚA QMS provides user-bound electronic signatures, time-stamped audit trails and role-based access. Your team remains responsible for its validation, procedures and regulatory compliance.

 

Yes. CAPA and change control can trigger SOP revisions in KOŚA DMS and training assignments in the LMS.

 

Yes. Bring your current quality logs or system. The walkthrough can cover data migration, configuration, validation and a rollout plan.