SQIP — Sparsh Quality Intelligence Platform | Patent Filed

The problem

Every repeat finding raises a question about the reasoning behind the previous CAPA.

Current quality systems record that a CAPA was completed. None evaluate whether the reasoning that produced it was sound. Early internal testing suggests this gap contributes to why the same finding recurs, inspection after inspection.

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

Enforcement costs

Regulatory enforcement carries significant direct and indirect costs — remediation, delayed approvals, operational disruption, consultant support, and reputational impact

How SQIP fits

Where SQIP sits in your quality ecosystem

SQIP is designed to operate above your existing systems — not replacing them, but governing the reasoning that happens between events and decisions.

→

Your eQMS

Records closure

Records that a CAPA was opened, progressed, and closed

→

SQIP

Governs reasoning

Governs the reasoning behind the investigation — before closure is permitted

→

Organisation learns

Retains signals

Reasoning patterns are retained and surfaced across future investigations

Goal over time

Reduce recurrence

Repeat findings can be reduced through better reasoning — not just better documentation

SQIP is being developed and validated. The above represents the intended design logic, not a proven outcome.

Positioning

A proposed 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. Sequential by design. No undocumented bypass.

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. Three on the roadmap.

Eight modules. Each one addresses a gap that no current eQMS, RBQM, or audit platform closes. Three are live today. Two are in active development. Three are on the roadmap. All operate above your existing systems — not instead of them.

Live

SQIP RCA

Causal Reasoning Engine

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

Live

SQIP CAPA

Intelligent CAPA Alignment

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

Live

SQIP Inspect

Inspection Readiness Engine

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

Building

SQIP Risk

Predictive Risk Intelligence

Prospective, QbD-aligned risk governance anchored to critical-to-quality factors. Designed to surface and govern quality risk before events occur — not after they are recorded.

Building

SQIP Assist

Real-Time Compliance Intelligence

Designed to provide structured, reasoning-based guidance at the moment of process execution — before issues become recordable events. Applies institutional learning from past RCA/CAPA cycles in real time.

Roadmap

SQIP Memory

Organisational Knowledge Graph

Propagates learning from closed quality events as advisory signals across sites, studies, and teams. Applies structured classification to distinguish systemic patterns from isolated events over time.

Roadmap

SQIP Oversight

Portfolio Intelligence

Designed to surface cross-portfolio quality signals — identifying systemic patterns across studies, sites, and programmes that individual module reviews cannot reveal.

Roadmap

SQIP Vendor

Vendor & Site Intelligence

Vendor and CRO oversight quality signal monitoring. Designed to generate structured governance response triggers when KPI degradation correlates with quality event patterns across vendor relationships.

Proof of concept

Internal proof-of-concept: 20 investigations. One consistent signal.

Internal proof-of-concept testing across GCP, GVP, GMP, and GLP/GCLP — 5 constructed cases each — tested across strong, moderate, weak, and biased input quality levels.

20/20

Constructed cases indicated system design failure patterns at root — not human error as the prior record stated. Internal proof-of-concept only.

14/20

Had a prior closed CAPA that SQIP's reasoning engine flagged as potentially not addressing the actual causal mechanism. Requires external validation.

Direct platforms identified in internal market mapping that focus specifically on governing reasoning quality rather than workflow completion — April 2026

GCP · GVP · GMP · GLP

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

Who SQIP is for

Built for quality professionals in regulated environments

SQIP is being developed for teams in life sciences organisations who need more structured, defensible quality reasoning.

Clinical development QA and compliance teams

Pharmacovigilance and safety oversight functions

Inspection readiness and regulatory affairs teams

Vendor oversight and CRO quality leads

Quality directors managing repeat findings or serious non-compliance

Clinical operations and data management quality functions

What SQIP is not

Important distinctions

SQIP is intended to sit above existing systems as a Quality Intelligence Layer — not to replace them.

✕Not another eQMS or document management system

✕Not a workflow tracker or task management tool

✕Not a generic reasoning engine or document generation tool

✕Not a replacement for your QA team, consultants, or regulators

✕Not a regulatory decision-maker — human accountability is always preserved

SQIP is designed to govern how quality reasoning is formed, challenged, justified, and retained — above the systems that record the outcome.

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 →

Platform overview

Download the SQIP one-page brief

A concise summary of the problem SQIP is designed to solve, the platform category, core modules, current proof-of-concept status, and how to start a design partner conversation.

PDF

SQIP One-Page Brief

Platform overview · Proof-of-concept status · Design partner invitation

Download the brief →

One page · PDF · Opens immediately