zentreon

▬ our presence ▬

Explore how we can transform your validation investment into measurable organizational benefits!

▬ meet our team ▬

Björn Adams

Chief Executive

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John Fenakis

Lead Consultant

Lucy Lucy

Deputy Consultant

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An AI-enhanced validation management support tool that centralizes Traceability Matrices, Risk Assessments, Change Management data, Test Case creation, and Audit Reporting for streamlined compliance and quality assurance in the life sciences industry.

zentreon is a powerful, database-driven hub that modernizes business process management by replacing fragmented Excel or Power BI–based spreadsheet setups. Every process, system, or dataset is captured as Process Unit - a central hub consolidating all process information, technical details, document and test traceability, and risk assessments - delivering full transparency, consistency, and governance across your organization.

This hub can integrate seamlessly with many key enterprise systems, including Change Management tools, eDMS, and even modern ERP solutions like SAP Signavio, SAP Cloud ALM, or test management systems, enabling semi or full automated end-to-end compliance, operational excellence, and streamlined change management.

AI capabilities assist in generating and maintaining risk assessment results, and automatically propose GxP - compliant test setups and scripts based on the risk analysis. Comprehensive reporting supports both internal and external audits, demonstrating full SDLC coverage for your processes, systems, and data.

Key
Features

AI-Driven Support

✦ Based on various fields, a local or open AI creates test cases. Test scope is based on the results of the risk analysis
✦ AI can also be used to verify manual entries and supplement them optimally
✦ Smart search helps identify relevant processes, risks, and historical decisions

Stronger Compliance Resilience

✦ Semi-automated workflows with database support prevent incomplete or duplicate entries
✦ Save time in creating risk analyses, traceability matrices, and design reviews documents
✦ Ability to create specific audit reports with just a few clicks

Risk-Based Validation

✦ Focus on what truly matters:  zentreon enables risk-based testing through a semi-automated, AI-driven risk assessment that intelligently identifies what requires testing
✦ Transparent risk analyses already specify what needs to be tested and what does not (formally)

Integration

✦ System integrations reduce double data entry and manual syncing
✦ Key elements like IDs, change references, and document links can be auto-mapped
✦ Depending on the degree of automation/ possibilities, the tool can continue to create your BPML, TRM, and test cases

Benefits

Stronger Compliance Resilience​

Reduces compliance risks through structured, audit-ready traceability
Eliminates duplicate entries
Always enables complete traceability of implementation and changes in processes

Fast & Targeted Process Searchability

Quickly find specific business processes, changes or test cases, with AI support when searching

Audit Support Built-In

Generate comprehensive, ready-to-present audit reports in just a few clicks

Risk-Based Validation at Its Core

Focus efforts where it matters: Zentreon supports risk-prioritized testing through a semi-automated comprehensive risk assessment and AI-powered suggestions on what needs to be tested

Interested?

Crafted with care by

Digital Innovation Factory

Founded in 2024, DIF builds on decades of software development experience. The company leverages proven technology from earlier successful ventures to unlock new markets with D-Flow Systems.

D-Flow Systems

D-Flow Systems was founded in 2022 and builds on more than 40 years of software experience in the medical industry. D-Flow supports this tool with its server structure and the basic development of the D-Flow software.

CSV lab

CSVlab AG is a Swiss consultancy specializing in SAP/ERP validation, with a strong focus on optimizing computer system validation (CSV) processes.