Computer System Validation Project
Computer system validation provides documented evidence that software applications meet their intended uses by testing the requirements. Computer system validation, essential for competent risk management, improves product reliability, increases patient safety, and ensures the systems are complying the regulatory requirements
How we implement CSV in your organization
We apply a Life cycle & Risk-based approach to the computer system validation (CSV) process ensuring the right amount of testing and documentation is undertaken. Our dedicated CSV experts who develop and implement system validation activities based on industry best practices and their significant industry knowledge.
Our approach also focus to saves our clients significant time and cost for the implementation of computerized systems.
We offers CSV services and it can be delivered at onsite or remote, based on client needs.
Computer System Validation Project
Computer system validation provides documented evidence that software applications meet their intended uses by testing the requirements. Computer system validation, essential for competent risk management, improves product reliability, increases patient safety, and ensures the systems are complying the regulatory requirements
- Validation Planning & Implementation
- Risk Management
- System Requirement Specifications
- Testing & Report Compilation
- Validation Summary & System Release
- Maintain the Computer System Validated state
Our CSV services for GxP regulated system as mentioned below, but are not limited to;
- Validation of new or existing Computerized Systems
- Develop and Implement CSV Policies and Procedures
- Gap Analysis for Computerized systems
- Compliance Auditing (Supplier Audits & Internal Audits)
- Customized CSV support