The QMSR enforcement deadline has passed.Are you inspection-ready today? Check Your Readiness

The Sentinel for
Compliance Intelligence

Surfaces potential compliance misalignments before they become inspection findings.

The Real Cost of Undetected Compliance Misalignment

When misalignment goes undetected, the consequences do not stay hidden. They surface as warning letters, recalls, audit findings, operational disruption, and significant financial exposure.

FDA Warning Letters

44 Warning Letters

Issued in FY2025, most involving Quality System Regulation (21 CFR 820) violations.

Source: FDA FY2025 Enforcement Data

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CAPA Deficiencies

~50% of Device Firms

CAPA deficiencies remain the most common inspection observation.

Source: FDA Inspection Observation Reports

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Recall Exposure

$10M–$50M+

Direct cost of major Class I recalls before litigation and reputational damage.

Source: FDA Class I Recall Cost Analysis

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Recall Resolution Time

Up to 2 Years

Serious medical device recalls can take years to fully resolve.

Source: FDA Medical Device Recall Database

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Training Compliance Gaps

67% of Audit Findings

Involve training deficiencies or outdated records.

Source: FDA 483 Observation Analysis

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Manual Audit Preparation

Weeks of Preparation

Teams still manually assemble inspection evidence across fragmented systems.

Source: Industry Quality Benchmark Report

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Why Suricat

Built for continuous compliance intelligence

Compliance does not fail all at once. It drifts quietly across documents, systems, and teams until an inspector finds what no system ever flagged. Suricat is that missing layer that makes alignment continuous.

Suricat's Mission

To transform regulatory compliance through explainable intelligence that detects misalignment early, preserves human accountability, and enables inspection-ready decisions.

Built by Practitioners

Suricat was built by practitioners with decades of experience in regulated environments, where documentation alignment determines whether organizations pass inspections, maintain approvals, and sustain operational continuity.

The Structural Problem

Compliance remains episodic in a world that demands continuous alignment. Organizations still rely on periodic reviews, manual reconciliation, and audit preparation cycles to validate compliance. Systems store records. Teams manage workflows. But no system continuously evaluates whether documentation remains aligned as requirements, processes, and evidence evolve.

Why Existing Systems Fall Short

Systems of record store documentation, enforce workflows, and preserve validation boundaries. They are essential and they will remain so.

What they were never designed to do is reason across documentation or evaluate whether alignment is sustained as systems and requirements evolve. They preserve information.

The Compliance Intelligence Platform

Suricat operates above existing systems of record to continuously maintain regulatory alignment across documentation ecosystems. It does not replace validated environments or disrupt existing infrastructure. It adds the capability those systems were never designed to provide.

How It Works

Suricat connects read-only to enterprise systems and structures documentation into a canonical intelligence model reflecting how regulatory requirements are interpreted in practice. It evaluates evidence credibility, reasons across documents and regulatory expectations, and identifies divergence as it emerges.

What Suricat Enables

Misalignment is identified early before it becomes an audit finding. Regulatory expectations are continuously evaluated against current documentation. Every conclusion traces back to source documents and governing requirements, creating the clarity and defensibility that inspection readiness demands.

Designed for Regulated Environments

Suricat preserves existing systems, validation boundaries, and human accountability. Its reasoning is explainable. Its outputs are inspection-defensible. Rather than replacing professional judgment, it strengthens it by providing structured, traceable intelligence that supports every regulatory decision.

Platform

How Suricat Works

Suricat introduces the Compliance Intelligence Platform, a new category built for regulated environments. It continuously evaluates alignment across documentation as it evolves, transforming compliance from periodic verification into a state that is always current, explainable, and inspection-ready.

The Intelligence Layer

Suricat operates as a neutral, read-only intelligence layer above existing systems of record. It does not replace validated infrastructure or alter system boundaries.

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No Rip and Replace

Your QMS, RIM platforms, document control systems, and validation infrastructure remain exactly as they are.

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Human Accountability

Suricat surfaces intelligence. Qualified professionals make every decision.

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Canonical Intelligence Schema

Every document entering Suricat is transformed into structured, traceable evidence that reflects how experienced regulatory professionals evaluate artifacts during inspections.

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Quality Validation Rating

Suricat continuously evaluates documentation through a confidence scoring system that determines inspection readiness.

high-tech circular gauge or dashboard interface showing a high validation score, glowing elements, dark background

Bounded Reasoning

Suricat's bounded reasoning engine is a proprietary architecture purpose-built for regulated environments where an incorrect output is not an inconvenience.

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The Regulatory Ontology

At the core of Suricat is a proprietary knowledge framework encoding how regulations are interpreted in practice.

complex 3d network graph representing a regulatory ontology, interconnected glowing nodes, dark background

Read-Only by Design

Suricat integrates across enterprise systems without modifying a single record.

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From Episodic to Continuous

Compliance has traditionally been managed as a periodic activity, where alignment is reconstructed before audits and inspections.

glowing infinity loop formed by data streams, symbolizing continuous compliance monitoring, dark background

Deployment

Suricat is delivered as a secure SaaS platform, enabling rapid adoption without disrupting validated environments.

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Built for highly regulated industries

Compliance intelligence wherever documentation alignment is mission-critical

Built for the compliance complexity of highly regulated industries — not adapted from generic tools.

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Medical Devices

FDA design controls, 21 CFR Part 820, ISO 13485, and the full DHF-to-submission compliance stack

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Biotechnology

Advanced therapy and biologics regulatory intelligence

Coming Soon

Pharmaceuticals and Biopharma

Comprehensive drug development and manufacturing compliance

Coming Soon

Clinical Trials

Trial master file and protocol alignment compliance

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