Internal audits, supplier audits, inspections — one workflow, zero spreadsheets.
Built by life science experts to simplify audit & compliance.
“Our last FDA inspection ran out of KOŚA. Every request was tracked, every commitment closed, nothing fell through.”
Improved traceability & automation
Replace manual coordination with structured, configurable workflows — with a full audit trail on every action.
Confident compliance
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 — inspection-ready by default.
Data-driven oversight
Monitor activity, backlogs and compliance KPIs in real time so leadership has the visibility it needs.
Faster implementation
Go live in weeks — not quarters — with structured rollout, training and 24/7 support.
From day one — every step controlled.
Annual audit programme
- Build a risk-based annual audit plan
- Schedule and assign auditors
- Track plan vs. actual execution
- Report progress to leadership
Audit execution
- Use configurable audit checklists by standard
- Capture findings inline with severity classification
- Attach evidence directly to findings
- Generate the audit report from validated content
Supplier audits & qualifications
- Maintain an approved supplier list
- Schedule re-qualification on a risk-based cadence
- Track supplier corrective actions
- Link suppliers to materials and incoming events
Regulatory inspection management
- Stand up an inspection war room in minutes
- Track requests, responses and commitments
- Link inspector observations to CAPAs
- Maintain a chronological inspection history
Everything A&C ships with.
Risk-based planning
Score auditees and prioritise the annual plan automatically.
Checklist library
Pre-built checklists for GMP, ISO and supplier audits.
Finding workflows
Route findings through response, CAPA and verification.
Inspection mode
Dedicated workspace for live regulatory inspections.
Supplier scorecards
Track quality, delivery and audit performance per supplier.
Trending
Spot repeat findings across sites and standards.
Designed to support the standards you’re audited against.
See A&C on your own data.
Bring a real scenario from your operations — we’ll show you exactly how Audit & Compliance handles it.