Patent Filed · Singapore · April 2026 · PCT Filing in Progress · 2026

Quality systems record what happened. SQIP governs how the reasoning got there.

The first GxP Quality Reasoning Governance platform. Enforces step-locked, sequential reasoning across investigations — not as a suggestion, as a constraint.

Not a workflow tool · Not an eQMS · Not automation · Not a decision-maker · Not a replacement for your QA team

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The problem

Every repeat finding is evidence the previous CAPA was wrong.

Current quality systems record that a CAPA was completed. None evaluate whether the reasoning that produced it was correct. That gap is why the same finding recurs, inspection after inspection.

Same finding.
New CAPA.
Same finding.

14/20

proof-of-concept investigations had a prior closed CAPA that did not address the actual causal mechanism

distinct root cause rejection classes identified — none detectable by any existing eQMS platform

$60M+

minimum cost of one FDA Warning Letter — preventable by one correctly governed investigation (FDA enforcement cost estimates, 2020–2024)

Positioning

A new category. Quality reasoning governance.

SQIP does not replace

✕Your eQMS — Veeva, TrackWise, MasterControl

✕Your RBQM or risk monitoring platform

✕Your QA team or regulatory consultants

✕Regulatory decision-making authority

✕Human accountability — ever

SQIP enforces

✓Step-locked reasoning before any CAPA can proceed

✓Causal alignment between root cause and corrective action

✓Evidence closure before conclusions are formed

✓Organisational learning signals from repeated failure patterns

✓A permanent, auditable reasoning record

The reasoning spine

7 gates. No bypass. No override. No exceptions.

Every investigation must pass all seven gates in sequence. No stage can be skipped, conditionally approved, or manually overridden.

Event ingestion

Structured event capture with input quality classification and completeness verification

GATE

Repetition signal

Prior occurrence detection independent of the eQMS — identifies recurrence before investigation begins

GATE

Control adequacy

Assessment of existing controls before root cause work is permitted to commence

GATE

Causal pathway

Five integrated frameworks: 5 Whys, Ishikawa, FTA, Barrier Analysis, Change Analysis — applied simultaneously

GATE

Root cause declaration

R1–R7 rejection taxonomy enforced — seven prohibited root cause labels including blame attribution, human error, and training gaps are structurally blocked regardless of accompanying text

GATE

CAPA alignment

Causal logic verified between the declared root cause and proposed corrective action — binary result

GATE

Effectiveness signal

Organisational learning record generated, locked, and made available for pattern detection

GATE

Platform modules

Three live. Two building. One on the roadmap.

Built by Sparsh Strategic Consulting — grounded in 25 years of GxP reasoning expertise. Each module is a standalone governance layer above your existing systems.

Live

SQIP RCA

Enforces the 7-gate Causal Reasoning Spine across every quality investigation. Applies five integrated RCA frameworks simultaneously and produces a structured, inspection-ready PDF investigation report on gate completion.

Live

SQIP Inspect

Evaluates organisational inspection readiness across six structured gates covering CAPA vulnerability, documentation integrity, and systemic risk. Produces a scored readiness report with a prioritised action plan.

Live

SQIP CAPA

Governs CAPA logic through five sequential gates, validating causal alignment between root cause and corrective action. Accepts root cause output directly from SQIP RCA, enforcing an unbroken reasoning chain from investigation to closure.

Building

SQIP Risk

Surfaces proactive quality risk signals by analysing patterns across investigations, CAPAs, and deviation histories. Produces a risk register with reasoning-based severity classifications rather than scoring alone.

Building

SQIP Oversight

Applies reasoning governance to vendor qualification and investigator site oversight. Enforces structured due diligence logic and produces auditable oversight records aligned to GCP and GDP requirements.

Roadmap

SQIP Memory

Captures and connects reasoning artefacts across all investigations to build persistent organisational learning intelligence. Surfaces recurring failure patterns and systemic root cause clusters that individual investigations cannot reveal.

Proof of concept

20 investigations. One consistent finding.

Across GCP, GVP, GMP, and GLP/GCLP — 5 cases each — tested across strong, moderate, weak, and biased input quality levels.

20/20

Cases showed system design failure at root — not human error as the prior record stated

14/20

Had a prior closed CAPA that SQIP determined had not addressed the actual causal mechanism

Direct competitors identified in global market analysis — no platform currently governs reasoning quality in GxP (Global market analysis conducted April 2026 — no platform identified that governs reasoning quality rather than workflow completion)

GCP · GVP · GMP · GLP

All four major GxP domains covered across 20 proof-of-concept investigations with varied input quality

Get involved

Two ways to engage with SQIP now.

For QA directors and heads of quality

Request a platform demo

See a live investigation run through the 7-gate reasoning spine. Bring a real scenario from your organisation. No software commitment required.

·60-minute structured demonstration

·Live case through RCA + CAPA governance chain

·PDF investigation report generated live

·No commitment required

Book a demo session →

For CROs, pharma QA teams, and investors

Join as a design partner

Work with Sparsh to validate SQIP against your real anonymised quality data. Shape the platform from the inside. Co-author the proof point.

·Shadow pilot using your historical anonymised data

·Co-authored case study for your organisation

·Priority access to all new modules

·Governed under mutual NDA and data agreement

Apply as design partner →