Engineered for Integrity
Yttrigen Inc. is a specialized technology firm providing strategic architecture, automated compliance, and software consultation for the regulated supply chain.
The Mission
Bridging the Gap Between Rigid Core and Agile Edge.
In the modern regulated enterprise, there is a dangerous disconnect. The Core Systems (SAP, Oracle) are secure but rigid. The Operational Edge (Labs, Warehouses) is agile but risky, often running on uncontrolled spreadsheets and "Shadow IT."
Our mission is to close this gap. We architect systems that bring the flexibility of modern software to the rigorous standards of 21 CFR Part 11 and GAMP 5 compliance. We don't just build software; we engineer trust.
Our Story: From ERP to Remediation
Yttrigen was founded on a decade of experience in Enterprise Resource Planning (SAP supply chain and logistics) implementation.
For years, we have been thinking deeply about compliance and system design, addressing challenges from audit trail assurance and regulatory compliance (21 CFR Part 820, ISO 13485) to process visibility and secure data sharing. This long-standing focus on solving complex operational problems in regulated environments has shaped our approach to technology architecture.
After years of deploying multi-million dollar supply chain systems, we observed a persistent pattern: critical quality decisions were still being made outside the system, in fragile Excel spreadsheets, because the ERP was too slow or costly to customize.
We realized that the industry didn't need more generic consulting; it needed a dedicated mechanism to retire these risks. This insight led to the development of ValidKeep™, our proprietary platform for automated GxP remediation, and the evolution of Yttrigen into a product-focused technology firm.
Our Model: Innovation & Consultation
Yttrigen operates as a hybrid technology partner:
- As a Consultancy: We provide high-level advisory services on Enterprise Architecture, AI Strategy, and Validation frameworks. We help organizations navigate the complexity of digital transformation in regulated environments.
- As an Incubator: We build and license purpose-specific platforms. Our flagship product, ValidKeep™, represents our philosophy of "Compliance by Design," baking regulatory controls directly into the infrastructure code.
Core Competencies
We bring multi-disciplinary expertise to every engagement:
Enterprise Architecture
Deep knowledge of SAP data structures, integration patterns, and supply chain logic. Experience with large enterprise deployments, integrations between supply chain and manufacturing, quality management and finance, as well as EDI, middleware, and other integration technologies including AS2.
Regulatory Compliance
Mastery of FDA, EMA, and ISO standards regarding data integrity and software validation.
Advanced Automation
We leverage AI in our development and design processes, but AI is not in the loop when running validated systems. Our serverless edge computing (Cloudflare) infrastructure delivers deterministic, validated outcomes at scale.
Our Values
Totality
We do not believe in partial solutions. We deliver the code, the infrastructure, and the documentation as a single validated unit.
Stability
We prioritize long-term maintainability over short-term trends. Our systems are built on "Frozen Artifacts" and open standards (SQL/JSON) to ensure data longevity.
Accountability
We embrace the responsibility of the "Quality Unit." We sign our work, and we stand behind our validation.
Leadership
Founder & Principal Architect
Our leadership brings over 20 years of experience in SAP supply chain and logistics implementation, large enterprise deployments, and GxP system validation. We have extensive experience with integrations between supply chain and manufacturing, quality management and finance, as well as EDI, middleware, and other integration technologies including AS2. We lead Yttrigen's strategic direction, focusing on the intersection of modern cloud infrastructure and federal compliance regulations.