Computer Systems Validation (CSV) Services

For over 10 years, PSC Biotech has been the primary Computer Systems Validation provider for this pharmaceutical client.

Area: Bay Area
Project Type:Computer System Validation (CSV)

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.