About this Project
OBJECTIVE
Computer System Validation (CSV) is the process of providing documented evidence that a computer system performs exactly as intended. The goal of this project has been to provide ongoing computer system validation services to the client, covering a wide range of enterprise and desktop applications.
SERVICES
PSC Biotech partners with the client to provide the following:
- IT-CSV project oversight
- Development of required CSV documentation as per client process and project schedule
- Execution of the relevant documentation
- Page-by-page review of the executed client documents
- Lab instrumentation/desktop upgrade support
- HPALM support
- Automated Testing support
- Project Management
- Business Analysis
- Date Entry Support
DELIVERABLES
The project deliverables include:
- Preparation of validation plans, specifications, support with relevant project meetings/ strategy and planning
- Development and execution of Installation, Operational and Performance Qualifications
- Preparation of Traceability Matrix, summary reports and other CSV documentation as required by the client.
- Business Requirements, workflows, project plans.
PROJECT SUCCESS
This project was completed successfully as per client specifications and in the expected time for completion.