Computer systems validation is a critical activity that helps life sciences companies ensure compliance with regulatory requirements, for proper validation throughout the supply chain.

CSC's computer systems validation practice helps life sciences organizations perform this important function in a regulated environment. From front-end planning to integrating and/or managing your technology solutions, we have the depth and experience to help you with your unique challenges and opportunities.

Through years of FDA-regulated application experience, CSC has created Good Practice (GxP) validation tools, training and system remediation solutions packages to help our customers with their regulatory activities and filings. Through these comprehensive and proven validation offerings, CSC customers are provided the detailed support needed to establish proper validation processes and ensure that compliance with the regulatory requirements is achieved in a timely and cost-effective manner.

CSC's validation solution concentrates on three key areas:

• Consultation
  CSC can conduct regulatory audits, help assess risk, help you plan your approach to validation, assess your validated systems and train your regulatory and IT personnel.
  
• Project Management
  CSC has experts who can apply CSC’s CatalystSM Methodology to manage site-wide or company-wide validation efforts as required by our clients. Catalyst is an end-to-end project management methodology that addresses the full enterprise life cycle — from strategy through operations — and provides industry best practices that CSC can integrate with a client’s own frameworks to manage their validation efforts.
  
• Resources
  CSC can provide skilled resources to help bring your company into compliance, augment your systems validation team, or function as a CSC-based validation team.