Business Systems Compliance
- Computer systems compliance
- Data migration and system validation
- Risk assessment, gap analysis and action plan
- Strategy and project management
Compliance Training
- Delivered in classroom or by WebEx and certificated for attendees
- Tailored for your specific application
- GMP, GLP, GCP, GDP and GAMP®(cGxPs)
- ICH, EU and FDA regulations
Compliance Audit
- Audit services delivered by qualified auditors
- Fixed price audits with established processes and tools
- Issue identification and remediation action prioritisation
Quality Consulting
- Validation and compliance improvement strategy
- Project management and performance measurement
- QMS design and implementation
- Expertise with GMP, GCP, GDP, GLP and GAMP®
IT Compliance
- Life Sciences cloud consulting including IaaS, PaaS, vendor audits
- Network qualification and validation
- Data centre audits and supplier audits
- Corporate Compliance
QP Services
- New licence approval
- Audit and regulatory inspection readiness
- Routine product release support
