IT-Consulting

• Software Engineering and Consulting for the regulated Industry (RISE)
• RISE-Consulting for Software Development Companies
• IT-QM-Systems: Analysis, Development, Optimization, Implementation Support
• IT-Service Management: Consulting and Conception of Service Organizations
• IT-System Management & IT Infrastructure Management
• Computerized System Validation (CSV)
• CSV/GAMP-Risk Analysis
• CSV/GAMP-Audits (internal, external)
• Development of IT-Concepts and Strategies

QM-Consulting

• Qualification & Validation of Infrastructures, Equipment and Systems
• Conception and Implementation Support of QS-Systems & Organization
• SOP-Development
• cGxP Audits (internal, external)
• cGxP-Risk Analysis (e.g. FMEA)

Process Analytical Technology Consulting (PAT-Consulting)

• Performance of PAT Readiness Assessments
• Development of the PAT Strategy and Concept
• Performance of PAT-Projects together with our PAT-Network Team
• Consulting & Support for Inspection Preparation
• Consulting & Support of PAT-Processes
• PAT-Audits (internal, external)

Management Services

• Project Management
• Project Controlling
• Audits and Performance Reviews of critical Project
• Project Quality Management/ Quality Management Services for Projects
• Project Coaching
• Training