Datascience & Software Engineering
From idea to compliant product: We combine modern software engineering with data expertise to build scalable, automated and inspection-ready solutions.
SOFTWARE DEVELOPMENT PROCESS & ENGINEERING LEADERSHIP
We establish efficient development processes with Git policies, code reviews, CI/CD and structured requirements engineering – or provide Engineering Lead as a Service for your team.
- Requirements management, architecture guidance, definition of done
- Git strategies (branching, PR reviews, release tags), CI/CD pipelines
- Code reviews, test strategy (unit/integration/E2E). QA processes
- Delivery management, technical steering & mentoring
DATA ENGINEERING, ETL & AUTOMATION
Designing and operating robust pipelines to move, transform and deliver data – with monitoring, lineage and restart capability. All solutions can be delivered with validation artifacts for regulated environments.
- ETL/ELT pipelines, data modeling & quality checks
- Automation of recurring tasks and deployments
- Bl/Analvtics (dashboards, KPIs) and self-service enablement
- Building data-driven applications from prototype to production
TECHNOLOGY STACK
Lanquages: Python, R, SQL, Typescript, HTML, CSS, Bash
Frameworks: Django, FastAPl, Angular, Quarto, Docker
Practices: Version control, test automation, CI/CD, containerization
IT-Compliance
We support regulated organizations in the Swiss healthcare and life sciences sector with practical, efficient and inspection-ready implementation of EU-GMP/GDP requirements. Our focus areas include Computerized System Validation (CSV) according to EU GMP Annex 11 and GAMP 5, robust authorization concepts, lean IT processes and demonstrable data integrity.
COMPUTERIZED SYSTEM VALIDATION (CSV)
Risk-based validation of computerized systems from concept to operations – including vendor assessments, SOP packages, traceability and change control – tailored for SMEs.
- Validation strategy & plan (VMP), risk analysis, traceability matrix
- URS/FS/DS, test planning (IQ/OQ/PQ), reporting & release
- Vendor and service provider assessments, audit preparation & support
- SOP package: CSV, Change/Deviation, Periodic Review, Backup/Restore, DR
AUTHORIZATION CONCEPTS & IT PROCESSES
Role-based, auditable access models with structured approval and re-certification processes. Streamlined IT processes from onboarding to incident/problem management.
- RBAC design, segregation-of-duties checks, access reviews
- Process maps & SOPs (on/offboarding, change, incident, DRP)
- Technical & organizational controls (backups, monitoring, logging)
- Inspection readiness (Swissmedic and internal audits)
DATA INTEGRITY
Ensuring compliance with ALCOA(+) principles: Data is attributable, legible, contemporaneous, original and accurate throughout its lifecycle. We help close gaps across technology, processes and documentation.
- Data flow analysis & critical control points (audit trail, timestamps)
- Integrity controls: audit trail review, backup/restore evidence
- SOPs and training for data integrity requirements
- CAPA development and effectiveness checks
We deliver tangible results instead of lengthy concepts – short cycles, transparency and compatibility with your requlatory requirements.