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.
Grounded in real-world audits, quality systems, and compliance programs, Suricat reflects the reality that documentation, evidence, and regulatory intent must remain continuously aligned as systems and requirements evolve.
It brings the structured reasoning used during inspections into a continuous intelligence platform that maintains alignment across documentation ecosystems.
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.
Misalignment develops quietly. It surfaces during audits and inspections when remediation is already costly and time is already short.
This is not a limitation of effort or process. It is a structural gap.
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. They do not ensure that information remains aligned under regulatory scrutiny.
The missing capability is not another system of record. It is a system of understanding that operates above them.
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.
Compliance transforms from a process of periodic validation into a capability of continuous alignment.
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.
Every finding carries full traceability to source documentation and regulatory intent. Every output is explainable, auditable, and defensible under inspection.
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.
It introduces the one capability those systems were never designed to provide — the ability to continuously reason across documentation ecosystems and detect misalignment before it becomes a regulatory consequence.
Your QMS, RIM platforms, document control systems, and validation infrastructure remain exactly as they are.
Every validated system remains validated. Every workflow continues unchanged. Every compliance boundary is preserved.
What changes is your ability to continuously maintain alignment across all of them.
Suricat surfaces intelligence. Qualified professionals make every decision.
No output influences a compliance decision without human review and documented disposition. Every finding is advisory, traceable, and inspection-defensible.
This is what makes the platform trustworthy in regulated environments where accountability is non-negotiable.
Every document entering Suricat is transformed into structured, traceable evidence that reflects how experienced regulatory professionals evaluate artifacts during inspections.
All reasoning is grounded in inspection-relevant context rather than generic interpretation.
Suricat continuously evaluates documentation through a confidence scoring system that determines inspection readiness.
Each document is assessed for:
This creates a system-level understanding of documentation integrity.
Suricat's bounded reasoning engine is a proprietary architecture purpose-built for regulated environments where an incorrect output is not an inconvenience — it is a compliance risk.
Inference is structured through the Canonical Intelligence Schema, anchored to the regulatory ontology, and validated against defined thresholds before any output reaches a reviewer.
Every finding carries complete, traceable lineage from source document to regulatory requirement to final disposition.
This architecture is proprietary to Suricat and cannot be replicated by adding guardrails to a general-purpose AI model.
At the core of Suricat is a proprietary knowledge framework encoding how regulations are interpreted in practice.
It captures clause-level relationships across standards, evidentiary expectations, and inspection behavior — closing the gap between regulatory text and real-world evaluation.
It is continuously refined through deployment, compounding in depth and precision as the platform scales.
Suricat integrates across enterprise systems without modifying a single record.
Existing infrastructure is preserved. Validation boundaries remain intact. Security, access, and audit requirements align with enterprise standards.
For regulated environments, read-only architecture is what makes adoption possible.
Compliance has traditionally been managed as a periodic activity, where alignment is reconstructed before audits and inspections.
Suricat establishes a continuous model where alignment is maintained as documentation evolves and issues are addressed at the point of emergence rather than the point of inspection.
Compliance is no longer something you prepare for. It is something you continuously maintain.
Suricat is delivered as a secure SaaS platform, enabling rapid adoption without disrupting validated environments. It connects in read-only mode to existing systems, preserving infrastructure while establishing continuous alignment across documentation.
The platform is built on Azure to meet enterprise expectations for security, identity, and governance, including tenant isolation, encryption, access control, and auditability.
Guided deployment enables smaller teams to get started quickly with minimal overhead, while managed onboarding supports larger organizations with structured integration and governance alignment.
On-premise and hybrid deployment are on the roadmap.
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.
Navigate the transition to the FDA's Quality Management System Regulation (QMSR). This comprehensive guide provides a detailed mapping between existing 21 CFR Part 820 requirements, ISO 13485:2016, and the new QMSR framework. Learn how to identify documentation gaps, update your quality manual, and ensure your organization remains compliant and inspection-ready under the new harmonized rules.
Master the documentation complexities of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This resource breaks down the stringent requirements for technical documentation, clinical evidence, and post-market surveillance. Discover strategies to maintain continuous alignment across your technical files and adapt to evolving notified body expectations.
A practical blueprint for implementing and sustaining an ISO 13485:2016 compliant Quality Management System. Moving beyond theoretical frameworks, this guide provides actionable steps for establishing documentation controls, risk management processes, and continuous improvement mechanisms that ensure long-term compliance and inspection readiness.
Continuous alignment for FDA design controls, QMSR, and ISO 13485.
Regulatory intelligence for advanced therapies and biologics.
Documentation compliance for drug development and manufacturing.
Organizations lose 2-4% of annual revenue to compliance failures. Discover how episodic validation leaves critical gaps in your quality management system...
With the FDA's shift to QMSR, aligning your existing 21 CFR Part 820 documentation with ISO 13485 requires more than a simple crosswalk...
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.