Computer System Validation
Computer System Validation Services
At Vantage Systems, we employ a risk-based approach to the computer system validation (CSV) process ensuring the appropriate amount of testing and documentation is undertaken. This approach to CSV saves our clients considerable time and money when implementing electronic systems. We have a dedicated team of CSV compliance experts who develop and implement system validation processes based on industry best practices and their expansive industry knowledge.
Our CSV services can be adapted and tailored to meet your organizational needs, leveraging our document templates library and professional services team. Our knowledge of life sciences software and systems is extensive, and can be leveraged in your next implementation project.
Our team of validation experts will work closely with your QA and IT teams, as well as software vendors to ensure that a coherent validation strategy is implemented in line with quality requirements, available resources and associated risks.
Executing validation testing can represent a significant part of overall effort when it comes to implementing GxP computerized systems. Vantage Systems’ Computer Systems Validation experts are able to hit the ground running and take on all aspects of validation execution.
21 CFR Part 11 and Annex 11 Regulatory Impact Assessment
An essential part of any GxP computerized system validation strategy, is understanding the impact that the system has from a regulatory perspective. Our Validation experts have many years of experience performing assessment of various computerized systems against the requirements of 21 CFR Part 11 and Annex 11 in order to demonstrate the compliance of an application with these regulations.
Risked Based Validation Planning
One crucial element of the Validation Planning process is risk assessment. When performing a risk assessment, experience is essential in order to be able to identify risk areas associated with the use of a GxP computerized system. Our Validation experts can work with you to create a validation plan that focuses on areas that pose a high regulatory and/or business risk to your organization in order to focus the validation effort, to diminish costs and speed up implementation time.
Our Validation experts have developed and executed validation test scripts for the vast majority of computerized systems found in clinical trial and pharmaceutical development.