We are able to offer services in the following areas:

System Life Cycle Management including:

• QMS Development
• Governance - Project Change Control, Configuration Management, Incident Management, Trace Management, Document Management
• Validation Planning and Reporting
• Requirements Elicitation and Definition
• Design and Design Review (DQ)
• Development Management
• Installation (IQ)
• Verification and Testing (OQ)
• Deployment, including: Business Change Management, Data Migration, SOP Development, Training, Continuity Planning, Disaster Recovery, Cutover and Initial Use (PQ)
• On-going Validation and Post Validation Review
• Inspection Preparation and Readiness

Specialist Application Areas include:

• Laboratory Information Management Systems
• Chromatography Data System
• Electronic Document Management Systems
• Data Warehousing for GxP Applications
• Manufacturing Execution Systems
• Electronic Batch Record Systems