The Engineering Approach
Validation is often treated as an administrative afterthought—controls layered onto a finished product. At Lionize, validation is treated as a consequence of architecture.
By combining nearly two decades of systems engineering with a decade of regulatory expertise, compliance is embedded into the software lifecycle. This reduces technical debt, ensures data integrity by design, and creates systems that are inherently defensible during audits.
Dev Lab & Prototypes
Consulting requires staying close to the metal. The Dev Lab serves as a sandbox for algorithmic experiments, state management patterns, and optimization logic.
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Services
⚙️ Strategy & Process
Building an audit-ready foundation before development begins. Validation strategy is derived from deep process understanding.
- BPMN 2.0 Modeling (ARIS) to visualize workflows.
- Translation of operator knowledge into formal Requirements (URS).
- Supplier Audits and Gap Analysis.
🧭 Validation & GxP
Execution of rigorous GAMP 5 validation lifecycles, ensuring systems are demonstrably fit for intended use.
- Risk Assessments (FMEA/GxFMEA).
- Authoring and Execution of IQ / OQ / PQ protocols.
- Lifecycle Management via Master Control, TrackWise, Veeva Vault or KNEAT.
🧠 Specialized Engineering
Solving technical challenges where standard QA capabilities end. Code-level analysis and custom implementation.
- Algorithmic Auditing for AI/ML models.
- Legacy System Remediation (Refactoring/Migration).
- Hardware/Software Integration (e.g., Fiscal/TSE).
Track Record
Developing validation frameworks for non-deterministic systems. Addressing the "Black Box" problem in GxP environments through algorithmic auditing and explainability strategies.
- Scope: GMP-critical MES Implementation (Siemens Opcenter) for vaccine production.
- Execution: Full lifecycle CSV including Electronic Batch Recording (eBR) verification.
- Deliverables: Authored IQ/OQ/PQ protocols, managed Deviation/CAPA workflows, and acted as technical liaison between Global Quality and Local Engineering.
- Provided SME support during audits of IT/CSV suppliers and service providers.
- Reviewed and released business-critical, CSV-relevant GMP documents (URS, test protocols, etc.).
- Conducted source code reviews to assess software quality and maintainability.
Architected a proprietary Point-of-Sale (POS) ecosystem involving embedded hardware (Raspberry Pi) and cloud synchronization.
- Direct implementation of the German TSE (Technical Security Equipment) fiscal standard.
- Full-stack development (Python/C++, Vue.js).
- Note: Company merged with natural person Daniel Bernard in 2024.
Institute of Construction Informatics. Conducted Java Programming tutorials for engineering students and contributed to the "Virtual Engineer" e-learning platform.
Consultation
For inquiries regarding CSV strategy, legacy remediation, or technical auditing.
Contact via Email