Stop over-validating.
Start defending confidently.
CSA360™ is the only platform purpose-built for Computer System Assurance — helping regulated organisations decide what to validate, how much, and why, then defend every decision during an inspection.
The hardest problem in computer system validation isn't doing it — it's deciding how much to do.
Most regulated organisations over-validate because they lack a consistent, defensible way to scope validation effort under CSA expectations. The result: wasted resources, frustrated teams, and inconsistent evidence that doesn't hold up under inspection.
Pain points your team knows too well:
- Validation effort has no clear link to actual risk
- CSA is interpreted differently across teams and projects
- Evidence is scattered, stale, and hard to defend
- Revalidation is triggered by habit, not by change risk
- Every new tool requires external consultants to adopt
Validate what matters, to the right depth, continuously — and defend it confidently.
CSA360™ is a Continuous Validation & Assurance Platform for pharma, biotech, and medical device organisations.
It is not a document management system. It is not a test execution tool. It is the decision layer sitting above your existing quality stack — making your validation programme smarter, leaner, and inspection-ready at all times.
The CSA360 Engine
Validation Decision Engine (VDM™)
Right-size every validation. Every time.
CSA360's proprietary Validation Decision Model uses a five-axis risk characterisation framework to calculate the exact validation approach required for any computerised system.
- Five risk axes: Intended Use Criticality · Data Integrity Exposure · System Complexity Index · Configurability & Vendor Independence · Data Classification Index
- Deterministic: Same inputs always produce the same outputs (regulatory gold standard).
- Fully transparent: Complete NRE computation is visible, with per-axis contributions.
- Replayable: Run historical decisions to demonstrate regulatory consistency.
Evidence Confidence Scoring (ECRM™)
Know if your evidence is strong enough before your inspector does.
Evidence isn't binary. CSA360 scores it across four dimensions: Source Quality × Completeness × Recency Decay × Change Resilience.
- Output: STRONG / ADEQUATE / MARGINAL / INSUFFICIENT — always know your exposure before an audit.
- Automated evidence reuse guardrails (ELIGIBLE / CONDITIONAL / BLOCKED).
- Evidence gap analysis: required types vs. collected, with ECS threshold checking.
Continuous Validation Monitoring (CVM™)
Change happened. Here's exactly what needs to happen next.
Capture a change event. CSA360 evaluates the risk delta and returns a proportionate, documented response. Every response is risk-justified and auditable.
- No action required: Documented and closed.
- Document only: Record and justify the change.
- Targeted revalidation: Only the affected scope, not a full re-qualification.
No more blanket revalidation triggered by instinct.
Inspection Defence Mode (IDREL™)
Walk any inspector through your validation story in 5 minutes.
CSA360 auto-generates five real-time inspection narratives from live system data — not templates. No scrambling before inspections. Your validation story is always ready.
- Evidence Sufficiency & Proportionality Assessment
- Continuous Validation Status & Regulatory Alignment
- Data Integrity Controls (ALCOA+ citations)
Validation Readiness Score (VRS)
A composite 0–100 readiness score for every system in your portfolio. See your entire validation posture at a glance. No competitor offers this.
Who It's For
| Role | What CSA360 Does For You |
|---|---|
| QA Head / Quality Director | Portfolio-wide validation posture, inspection confidence, reduced noise. |
| Validation Lead / CSV Lead | Clear, defensible scope — no more guesswork or over-documenting. |
| Digital Quality / IT Quality Partner | Fast, predictable, consistent validation outcomes. |
| Inspection & Audit Teams | Read-only inspection view with pre-built, data-driven narratives. |
How It Compares
Every competitor assumes the validation decision has been made. CSA360™ makes the decision — and proves it was right.
Validate what matters.
Prove every call.
Request a DemoCSA360™ is a product of Akatalyst — built for regulated industries that can't afford to get validation wrong.