Computer Software Assurance for Production and Quality System Software
Draft Guidance
This CDRH webinar discusses the draft guidance titled, Computer Software Assurance for Production and Quality System Software, which is intended to provide recommendations on computer software assurance for computers and automated data processing systems that are used as part of medical device production or the quality system.
Why QbD Group?
Computer system validation, or CSV, remains as critical as ever, from automation and digitization to artificial intelligence and machine learning.
QbD has years of experience with numerous projects in various GxP environments. If required, our validation approach can be tailored to newer technologies, such as machine learning and artificial intelligence.
We are happy to help you:Â
- understand the processes in which your computerized system is used
- understand the functioning of your computerized system (white-box approach)
- decide on the lifecycle and Computer System Validation approach
and ensure highly consistent data and compliance with all relevant regulations. The first step towards data integrity!
Are you looking for CSV services? QbD offers CSV expertise to help your company comply with the latest regulations. Don’t hesitate to contact us for more information.
Tailored approach
The actual approach and life cycle you want to take to validate your computerized system(s) is up to you.
The most common and recognized CSV approach is the GAMP5 methodology.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right Computer System Validation services.
