Sempai Consulting
IT consulting and software provider focused on IT-supported enterprise planning, validated IT systems and regulatory compliance for regulated life-science industries (pharmaceuticals, biotech, medtech). Offers consulting (process analysis, system selection, project management), validation and change-management services, custom software development, and a modular GxP-compliant ERP/MES solution for mid-sized producers.
Industries
Nr. of Employees
small (1-50)
Sempai Consulting
Berlin, Berlin, Germany, Europe
Products
Pharma all-in-one ERP/MES system (modular, GxP-compliant)
Modular software covering procurement, inventory, batch traceability, production planning and control, cost calculation, electronic manufacturing instructions, QC workflows, CAPA, deviations, change management, stability programs and PQR generation; designed for integration with standard ERP/finance systems and industry messaging.
Pharma all-in-one ERP/MES system (modular, GxP-compliant)
Modular software covering procurement, inventory, batch traceability, production planning and control, cost calculation, electronic manufacturing instructions, QC workflows, CAPA, deviations, change management, stability programs and PQR generation; designed for integration with standard ERP/finance systems and industry messaging.
Services
Consulting on IT strategy, system selection, process analysis and embedding IT into corporate governance for regulated-industry clients.
Assessment, planning and execution support for validation of computerized systems and controlled change processes aligned with GAMP and FDA guidance.
Design and implementation of bespoke software applications and integration with ERP/finance systems and industry messaging standards.
Structured support processes for product and service customers, with documented email-driven request handling for traceability.
Consulting on IT strategy, system selection, process analysis and embedding IT into corporate governance for regulated-industry clients.
Assessment, planning and execution support for validation of computerized systems and controlled change processes aligned with GAMP and FDA guidance.
Design and implementation of bespoke software applications and integration with ERP/finance systems and industry messaging standards.
Structured support processes for product and service customers, with documented email-driven request handling for traceability.
Expertise Areas
- IT consulting for regulated industries
- GxP compliance and validation
- Pharmaceutical manufacturing IT / MES
- ERP and finance system integration
Key Technologies
- Microsoft enterprise technologies
- ERP integration (SAP, Microsoft Dynamics, Oracle, Infor, Sage)
- MES and pharmaceutical production workflows
- LIMS integration