Team
David Kühl
MES consultant with deep expertise in Körber PAS-X, focused on translating manufacturing processes into compliant, efficient electronic workflows. I design and optimize MBR solutions for pharma and biotech, support validation and go-lives, and ensure systems integrate smoothly into regulated production environments. My approach is structured, technically grounded, and committed to delivering practical digital solutions that work.
Key Experiences
- Design, configuration, and enhancement of PAS-X MES solutions across greenfield and brownfield projects
- Development of electronic Master Batch Records (eMBR/MBR) tailored to manufacturing workflows
- Translation of paper-based processes into robust, GMP-compliant digital execution
- Support for integration with ERP, LIMS, and level 2 systems
- Onsite and remote go-live/hypercare support for deployments and validation batches
- Support of computerized system validation (CSV/CSA) activities including risk assessments
- Development and review of validation documentation aligned with GAMP standards
- Execution of FAT/SAT testing and documentation for regulated systems
- Management of change controls (TrackWise) and test case reviews (HP ALM)
- Development of standardized CSV frameworks, templates, SOPs, and GxP training
- Management of PAS-X Content Package lifecycle for enhanced labels and reports
- Implementation and maintenance of standardized content across production sites
- System configuration aligned with data integrity (ALCOA+) and regulatory requirements
- Guidance through ERP selection processes for pharmaceutical clients
- Technical advisory on MES strategy, system architecture, and integration concepts
- Support for clients in scoping and structuring digital transformation roadmaps
Technologies & Knowledge
Domains
- PAS-X MES (V2.x–V3.x)
- GMP/GxP compliance, GAMP standards
- Electronic Master Batch Records (eMBR)
- Process validation & data integrity
Platforms & Tools
- Körber PAS-X
- TrackWise, HP ALM
- SAP ECC integration
- Veeva QualityDocs
Methods
- MBR design & workflow modeling
- Risk-based validation (CSV/CSA)
- FAT/SAT execution
- Change management & training delivery
Ready to bring your digital vision to life?
Let's work together to develop innovative solutions that stand out in the digital landscape. Contact us today and let's create something extraordinary together.