computer system validation


Also found in: Dictionary, Medical.

computer system validation

The certification that a computer is operating according to specification. It includes the observation of the hardware, software, connected instruments, as well as the practices trained staff employ while running the system. See software validation.
Mentioned in ?
References in periodicals archive ?
About the Speaker: Founder of Computer System Validation (CSV), David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIP and Computer System Validation.
Another important piece to include is the location of the computer system validation documentation, as this is not only important from a storage aspect, but also an access point of view.
The Institute of Validation Technology, a division of Advanstar Communications, has announced its Computer System Validation conference.
The conference will also feature more than 10 case studies, researched and presented in conjunction with industry experts, as well as a timely pre-conference workshop on The Essentials of a Computer System Validation System, facilitated by Erik Muegge, Assistant Director, Technology Compliance, Alcon Corp.
As session chair, Hulihan will lead a discussion on the key requirements needed for computer system validation to demonstrate data integrity and meet regulatory and industry best practices.
These services, which are provided both on site and on a consulting basis, include the placement of skilled professionals for regulatory planning, operations development, computer system validation, and ensuring U.
In 2006, Taratec and MODA entered into a professional services agreement that leverages Taratec's vast computer system validation and laboratory automation expertise in the implementation MODA-EM.
23rd Annual SQA Meeting April 29-May 3, 2007, Austin, Texas Speaker: Earl Hulihan, Vice President of Global Regulatory Affairs and Quality Assurance Session Title: "Practical Computer System Validation for Management" May 1, 2007 at 11:00 - 11:30 a.
Rob, a Senior Validation Manager at CSSC, is a recognized expert in computer system validation and 21 CFR Part 11 compliance.
php), participants will learn how today's leading Life Science's organizations use standards-based electronic signature technology to comply with the FDA's 21 CFR Part 11, GxP, Computer System Validation, internal SOPs, and industry standards such as SAFE to improve business processes.
For these companies, computer system validation is key to ensuring their systems meet overall business objectives and comply with industry regulations.
This new version of TraceGuard has been specifically designed to address the unique requirements of the industry, including 21CFRPart11 and computer system validation.

Full browser ?