Consultancy
We offer a best in class CSV consultancy service to all clients and partners
GxP Projects
We offer project-based consultancy scalable to your needs. From IT/CSV project managers and IT Directors to Project Leads, CSV Consultants and Testers.
Documentation and Templates
We have developed skeleton templates over years of executing projects, both specification and requirement to test protocols, reports and trace matrices.
Knowledge Disciplines
- Compliance With Part 11, Annex 11 and GMP EUdralex Vol4
- Data Integrity – ALCOA+
- Computer System Audit and Inspection Readiness
- Consultation for Government Funded Projects
- GAMP5 Life cycle approach to development and deployment of Systems
- GxP Training
- ISO13485 - Medical Devices Quality Management
- IT Project Governance, ensuring that the IT projects are validated to EU/FDA pharmaceutical regulations
- ITIL Service Level Agreements (SLA)
- Network and Infrastructure Qualification
- Process Analytical Technology (PAT)
- Risk Control Strategies and Assessments