The Compliance Intelligence Platform Built for Highly Regulated Industries Learn more
Suricat is the Compliance Intelligence Platform for highly regulated industries. It operates above existing systems to reason across documentation, detect divergence early, and produce inspection-defensible findings without replacing a single system beneath it.
Most organizations are not inspection-ready. Misalignment across design controls, risk, CAPA, and submissions remains hidden until it becomes a costly finding. Suricat makes these gaps visible early, so you can fix them before inspectors do.
Suricat transforms regulatory compliance from episodic validation into continuous alignment, operating above existing systems to detect misalignment early and maintain inspection readiness.
$14.82M vs $5.47M
non-compliance costs 2.7× more than staying compliant.
Ponemon Institute / Globalscape
Learn more2–4%
of annual revenue lost to compliance failures and remediation.
International Quality Federation / ASQ
Learn more417% surge
in fines (H1 2025) $1.23B in penalties in just six months.
Fenergo / FinTech Global
Learn more85%
of executives report compliance requirements are becoming more complex.
PwC Global Compliance Survey 2025
Learn more64%
of CEOs identify regulation as the top barrier to performance.
PwC Global Compliance Survey 2025
Learn more$63B → $135B
by 2030 investment reflects the scale of the problem.
MarketsandMarkets / Grand View
Learn moreCompliance 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.
To transform regulatory compliance through explainable intelligence that detects misalignment early, preserves human accountability, and enables inspection-ready decisions.
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.
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.
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.
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.
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.
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.
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.
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.
Suricat operates as a neutral, read-only intelligence layer above existing systems of record. It does not replace validated infrastructure or alter system boundaries.
Your QMS, RIM platforms, document control systems, and validation infrastructure remain exactly as they are.
Suricat surfaces intelligence. Qualified professionals make every decision.
Every document entering Suricat is transformed into structured, traceable evidence that reflects how experienced regulatory professionals evaluate artifacts during inspections.
Suricat continuously evaluates documentation through a confidence scoring system that determines inspection readiness.
Suricat's bounded reasoning engine is a proprietary architecture purpose-built for regulated environments where an incorrect output is not an inconvenience.
At the core of Suricat is a proprietary knowledge framework encoding how regulations are interpreted in practice.
Suricat integrates across enterprise systems without modifying a single record.
Compliance has traditionally been managed as a periodic activity, where alignment is reconstructed before audits and inspections.
Suricat is delivered as a secure SaaS platform, enabling rapid adoption without disrupting validated environments.
Built for the compliance complexity of highly regulated industries — not adapted from generic tools.
FDA design controls, 21 CFR Part 820, ISO 13485, and the full DHF-to-submission compliance stack
View industry pageAdvanced therapy and biologics regulatory intelligence
Comprehensive drug development and manufacturing compliance
Trial master file and protocol alignment compliance
Practical guidance for continuous alignment with evolving FDA and EU documentation standards to support continuous compliance and inspection readiness.
The FDA's Quality Management System Regulation became effective on February 2, 2026. It replaced the decades-old Quality System Regulation and incorporated ISO 13485:2016 by reference into 21 CFR Part 820.
The European Medical Device Regulation and In Vitro Diagnostic Regulation have fundamentally raised the standard for documentation coherence across the product lifecycle.
ISO 13485:2016 is now enforceable as part of FDA regulation under 21 CFR Part 820. For organizations that previously operated under the QSR without ISO 13485 certification
Continuous alignment for FDA design controls, QMSR, and ISO 13485.
Regulatory intelligence for advanced therapies and biologics.
Documentation compliance for drug development and manufacturing.
Documentation drift does not announce itself. It begins with a design revision here. An updated procedure there. A regulatory requirement...
The QMSR did not simply update terminology. It changed the fundamental basis on which FDA evaluates quality management systems during...
A comprehensive analysis of how episodic compliance models fail to maintain alignment across quality systems, leading to costly remediation and delayed market access.
This report outlines the structural shift required in enterprise compliance maturity — moving from reactive data collection and episodic audits to deploying continuous, agentic intelligence systems that automate complex regulatory alignment.
Drawing on Suricat's experience across highly regulated industries like medical devices and life sciences, it illustrates how organizations can transition from siloed systems of record to a unified intelligence layer. Whether you are navigating the QMSR transition or modernizing your quality infrastructure, this playbook provides a strategic roadmap for maintaining inspection readiness.
Quality assurance leaders face an unprecedented challenge: maintaining continuous compliance in an environment where documentation requirements evolve faster than traditional QMS systems can adapt. Recent FDA inspection data reveals that 73% of major findings stem from documentation misalignment—gaps that develop quietly between periodic audits and surface only when inspectors arrive...
QA Leadership Insights
Continuous compliance strategies
The FDA's transition to the Quality Management System Regulation (QMSR) represents the most significant shift in medical device compliance requirements in decades...
Design controls failures account for nearly 40% of FDA inspection findings, yet most organizations struggle to maintain real-time visibility into control effectiveness...
Corrective and Preventive Action (CAPA) systems are designed to prevent recurrence, yet studies show that 60% of repeat findings involve previously addressed issues...
Get the latest insights on FDA compliance, quality system management, and regulatory best practices delivered directly to your inbox.
Find answers to the most common questions about Suricat's Compliance Intelligence Platform
No. Suricat operates above your existing systems without modifying, replacing, or disrupting them. Your QMS, RIM platforms, document control systems, and validation infrastructure remain exactly as they are. What changes is your ability to continuously maintain alignment across all of them.
No. Suricat connects in read-only mode only. No document is ever modified, moved, or deleted. Every validated system remains validated. Every workflow continues unchanged. Every compliance boundary is preserved.
Every customer environment is fully isolated. No customer data is shared across tenants, used to train models, or retained beyond defined governance boundaries. All data is encrypted in transit and at rest. Identity and access management, role-based access controls, and audit logging ensure that only authorized personnel access platform outputs.
Suricat currently supports QMSR, ISO 13485, and MDR as primary frameworks. Additional regulatory frameworks are continuously added to the regulatory ontology through ongoing practitioner calibration and deployment experience. Organizations operating under specific frameworks not listed are encouraged to reach out directly to discuss current and roadmap coverage.
Suricat is designed to operate within regulated environments and is built to support customer validation activities. Full validation documentation, installation qualification and operational qualification support materials, and data processing agreements are available for enterprise procurement and IT review.
Suricat is delivered as a cloud-native SaaS platform hosted on Microsoft Azure.
Guided self-service deployment supports smaller organizations with rapid setup and minimal implementation overhead.
Managed onboarding supports larger and more complex environments with structured implementation covering system integration, ontology calibration, and workflow configuration.
On-premise and hybrid deployment options are on the roadmap.
