Innovative Technology Solutions for Tomorrow
Predictive PQS Intelligence Platform
Quality failure
is predictable.
We prove it.
NEXUS converts your existing operational quality data into leading intelligence indicators — detecting system instability 12–18 months before regulators find it.
12–18
Months early warning before regulatory findings
12
Predictive signals from your existing PQS data
5
Composite intelligence indices — SSI, FI, RI, QCI, BEI
Zero
New systems or integrations required
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The Problem
Quality systems
don't predict failure.
They report it.
Every major quality failure — recalls, 483 observations, consent decrees — was preceded by months of visible signals. Nobody connected them in time.
Data Reality
Fragmented. Siloed. Backward-looking.
Quality data lives in eQMS, ERP, LIMS, Excel and SharePoint — disconnected and never combined into a unified signal. Deviation lists, CAPA trackers and audit reports show what happened. Not what is forming.
Oversight Reality
Audits are point-in-time snapshots.
Mock audits capture a moment. Inspections arrive without warning. Internal reviews rely on experienced intuition. None of these approaches detect the slow accumulation of systemic pressure that precedes every major quality event.
Regulatory Reality
Inspectors look for signals you already have.
FDA 483 observations and EU GMP critical findings consistently map to the same leading indicators — CAPA recurrence, investigation quality, supplier deviation acceleration. These exist in your data months before inspection.
Business Reality
The cost of finding out too late.
A single consent decree costs $100M–$500M in remediation and lost revenue. A Class II recall runs $10M–$100M. An unplanned FDA warning letter adds 12–18 months of remediation overhead. These are preventable events.
"Quality systems do not predict failure. They identify problems after they occur. Regulators increasingly expect you to detect them before they do."
The NEXUS Insight
Every failure follows
the same curve.
Weak signals appear first — invisible to traditional systems. Then deviations accumulate. Then product issues emerge. Then compliance events occur. NEXUS detects the curve at its beginning, not its end.
NEXUS Early Warning Curve — Typical Failure Progression Timeline
Months –12 to –18
Weak Signals
CAPA recurrence rising. Investigation quality slipping. Supplier deviation rate creeping. Invisible to traditional metrics.
Months –6 to –12
Deviations Accumulate
Major deviation rate increases. CAPA backlog grows. OOT recurrence accelerates. Pattern detection now active in NEXUS.
Months –2 to –6
Product Issues
OOS results, batch failures, complaint escalation. System under visible stress. Traditional QA now responding — reactively.
Month 0
Compliance Event
FDA 483. Warning letter. Recall. Consent decree. This was predictable. NEXUS detects the pattern before this point is reached.
Architecture
Five intelligence
layers. One platform.
Each layer builds on the one below. Raw operational data — which you already possess — is progressively transformed into predictive executive intelligence without requiring any new systems or integrations.
01
Data Foundation
Your Existing PQS Data
Deviations, CAPA, complaints, supplier events, audit findings, change controls. Already in your eQMS, Excel, SharePoint. No new systems. No new integrations. Excel exports are sufficient.
Zero setup
Use what you already have
02
Signal Layer
12 Predictive Data Signals
Raw data is transformed into leading indicators — CAPA overdue rate, OOT recurrence, release RFT, near-miss rate, supplier deviation acceleration. Each signal is mapped to FDA and EU GMP expectations. Leading indicators, not lagging KPIs.
S1–S12
12 pilot signals
30 core / 60 extended
30 core / 60 extended
03
Operational Control Layer
Are We In Control?
Signals combine into the System Stability Index — a single, continuously updated score for PQS structural health. Replaces the point-in-time mock audit with continuous, objective control visibility across PQS Governance, CAPA, Product Lifecycle, Supplier Network and GMP System Control.
SSI
System Stability Index
PQS Health Score
PQS Health Score
04
System Behaviour Layer
What Will Fail Next?
This is where NEXUS becomes genuinely predictive. The Fragility Index detects where the system is likely to break — recurrence, backlog pressure, process variability, emerging risk signals. The Resilience Index measures the system's ability to absorb and recover from that pressure.
FI + RI
Fragility & Resilience
Emerging quality risk
Emerging quality risk
05
Executive Intelligence Layer
Why Is This Happening?
The top layer translates PQS performance into organisational maturity intelligence. The Quality Culture Index answers whether this is a culture or discipline problem. The Business Excellence Index measures whether the organisation can reliably sustain supply of quality product at scale.
QCI + BEI
Culture & Excellence
Maturity intelligence
Maturity intelligence
The 12 Pilot Signals
The signals that
precede every 483.
Each signal is derived from data your QMS already captures. Each maps to a specific FDA system inspection category or EU GMP expectation. Together they form a continuous early-warning system.
S1 · Governance
Management Review Action Closure Rate
Measures leadership engagement and governance effectiveness. Low closure predicts weak PQS oversight at the top.
FDA QSR §820.20 · EU GMP Ch. 1
S2 · Governance
Escalation Timeliness for Critical Issues
Time between event occurrence and formal escalation. Delays signal fear culture or poor transparency — both inspection red flags.
FDA 483 Category · EU GMP §1.12
S3 · CAPA
CAPA Effectiveness Verification Pass Rate
The proportion of CAPAs that pass effectiveness verification. Declining pass rate is one of the strongest single predictors of repeat findings.
FDA #1 483 Category · EU GMP Ch. 8
S4 · CAPA
CAPA Overdue Rate
CAPAs open beyond agreed timelines. Inspectors interpret this as lack of management oversight. Drives FI Backlog Pressure container.
21 CFR §211.192 · EU GMP Ch. 8
S5 · Investigation
Human-Error Root Cause Overuse
Proportion of deviations classified as human error. High rates indicate superficial RCA — the substrate from which all recurrence grows.
FDA Investigation Guidance · EU GMP Ch. 8
S6 · Product
QA/QP Release Right-First-Time
Batch release without additional queries or holds. Declining RFT is a leading indicator of process drift reaching the release gate.
EU GMP Ch. 4 · FDA 21 CFR §211
S7 · Product
OOT Recurrence Rate
Out-of-Trend events that recur within 6–12 months. Recurrence indicates CAPA is not resolving the underlying process cause.
FDA OOS Guidance · ICH Q10
S8 · Market
Complaint Rate per Batch
Market complaint frequency normalised to batch volume. Escalation indicates manufacturing issues reaching the patient or market level.
21 CFR §211.198 · EU GMP Ch. 8
S9 · Supplier
Supplier Deviation Rate
Deviation acceleration at supplier sites. A 35% increase over 3 months is a documented predictor of subsequent inspection focus on supplier oversight.
FDA Supplier Oversight · EU GMP Ch. 7
S10 · Supplier
Contract Audit Finding Recurrence
Repeat audit finding categories across cycles. Recurrence indicates an ineffective audit programme — a specific 483 observation category.
EU GMP Ch. 7 · FDA Audit Guidance
S11 · Culture
Near-Miss Reporting Rate
Near-miss volume relative to deviation volume. High ratio signals a healthy reporting culture. Declining rate predicts transparency deterioration.
FDA QMM Framework · ICH Q10 §3
S12 · GMP
Repeat Self-Inspection Findings
Findings that recur across self-inspection cycles. Strongly predicts regulatory findings at subsequent external inspection visits.
EU GMP Ch. 9 · FDA 21 CFR §211.68
The NEXUS Answer
Four questions no
current system answers.
01
Are we stable right now?
→ SSI · PQS Health Score
A continuously updated single score for PQS structural stability — objective, auditable, and traceable to signal data. Replaces the subjective mock audit snapshot with a live control view updated every month.
02
Where might we fail next?
→ FI · Emerging Quality Risk
The Fragility Index detects where system pressure is building before it becomes visible as a deviation or product event — 12–18 months before the compliance event that would result.
03
Are we inspection-ready today?
→ IRS · Inspection Readiness Score
A single number derived from all indices, aligned to FDA and EU GMP inspection priorities. Becomes a live QA/QP decision assessment and a monthly regulatory risk indicator — without the cost of a mock audit.
04
Are we learning or repeating?
→ QCI · Quality Culture Index
The Quality Culture Index reveals whether the organisation is genuinely learning from events or cycling through recurrence. This is the diagnostic most companies cannot answer — and inspectors increasingly probe for it.
Why NEXUS
A different category
of product entirely.
NEXUS is not an eQMS replacement. It is a predictive intelligence layer that sits above your existing systems and turns what you already know into what you need to know.
| Dimension | Traditional Approach | NEXUS |
|---|---|---|
| Data view | Fragmented across eQMS, ERP, LIMS, Excel — never combined into a unified signal | Single unified intelligence layer over all existing systems — no integration required |
| Orientation | Backward-looking. Deviations, CAPA lists and audit reports show what has already happened | Forward-looking. Detects systemic pressure 12–18 months before it becomes a compliance event |
| Inspection readiness | Point-in-time mock audit, typically 2–3 days, €8–15K, conducted once or twice a year | Continuous, monthly inspection readiness score — objective, auditable, FDA/EU GMP aligned |
| Management input | Dashboards showing lagging KPIs. QA/QP relies on experience and intuition to interpret them | Executive-level intelligence — system maturity, culture health, operational excellence — not another KPI dashboard |
| Supplier oversight | Periodic audits. SLA reports. No early signal between formal review cycles | Continuous S9/S10 supplier signal tracking — deviation acceleration and audit recurrence detected as they form |
| Technology | Requires QMS implementation, configuration, training and ongoing administration investment | Zero new systems. Works from Excel exports. Operational in 5–6 weeks from data submission |
| Output | Reports on what happened. Provides compliance documentation | Predicts what is forming. Proposes preventive management interventions before escalation occurs |
Unique Value
Three things
NEXUS is not.
Not another eQMS
NEXUS sits above existing quality management systems and is driven by system intelligence data, not process transaction data. It does not replace the QMS — it analyses it. No configuration. No validation overhead. No adoption project.
Not a KPI dashboard
Dashboards show lagging metrics. NEXUS detects systemic patterns — signal clusters, index trajectories, emerging risk combinations — that no single KPI can reveal. It operates at the level of system behaviour, not individual measurement.
Not intuition-led
Most PQS oversight depends on experienced QA professionals interpreting data through intuition. NEXUS is objective, auditable, and reproducible — generating a traceable evidence trail that satisfies regulatory expectations for data-driven quality management.
Get Started
A 5-week pilot.
24 months of insight.
The NEXUS pilot delivers a data-driven alternative to a traditional mock GMP audit — using your existing operational data, anonymised, with no system integration required.
W1
Screening & Scoping
Initial interview to understand your data landscape, quality system structure, and primary areas of concern. We confirm data availability and agree the anonymisation approach.
W2
Data Submission
You provide structured operational datasets — deviation log, CAPA tracker, complaints, supplier events, audit findings. Excel exports are sufficient. No system access required.
W3
Signal Analysis
NEXUS processes 24 months of data across 12 predictive signals. Index scores computed. Patterns identified. Decomposition analysis links signals to entities and root themes.
W4
PQS Intelligence Assessment
SSI, FI, RI, QCI, BEI and IRS scores computed across the full 24-month window. Inspection readiness risk register generated. Maturity level assessed against FDA QMM framework.
W5–6
Executive Review & Handover
Findings presented to QA leadership and executive team. Recommended interventions reviewed and assigned. 3-month post-pilot PQS monitoring report included — equivalent to a structured self-inspection.
Pilot Investment
€10,000
Equivalent to a 3-day traditional mock GMP audit
Deliverables
PQS baseline stability assessment — 24 months
FDA QMM maturity level score
Inspection Readiness Risk Register
Emerging Quality Risk analysis (FI)
Quality System Effectiveness profile (RI)
Predictive intervention recommendations
3-month post-pilot monitoring report
All data anonymised. NDA and data processing agreement provided before submission. Secure storage. Deletion upon completion.
Your data already contains
the answer. We just read it.
the answer. We just read it.
Every quality failure was preceded by months of visible signals in data the company already held. NEXUS exists to ensure that data is read — continuously, objectively, and before it becomes a problem.