Computer system validation has been regulated by FDA for ... management and reporting systems, clinical trial sample manufacturing, testing and labeling systems, and all of those systems used ...

This process, known as Computer Systems Validation (CSV ... process compared to a paper-trail and ink signatures. As an example, in the USA, the Food and Drug Administration (FDA) provides ...

Examples from industry will be used as ... to meet FDA expectations .It is the best practice to have a robust computer system validation, continue executing against it consistently, and ...

This seminar is intended for those involved in planning, execution and support of computer system validation activities ... clinical testing and management, sample labeling, adverse events management ...

Historically, the industry has followed the practice of Computer System Validation (CSV), which is ... of remaining in compliance. For example, teams should understand data across their systems ...

1 The CSA Draft Guidance is intended to provide clarity regarding FDA’s expectations for the validation ... for computer software used to automate compliance to quality system / CGMP (Current ...

This webinar is intended for those involved in planning, execution and support of computer system validation activities ... clinical testing and management, sample labeling, adverse events management ...

DUBLIN--(BUSINESS WIRE)--The "Computer System Validation Boot Camp" training has been added to ResearchAndMarkets.com's offering. Boot camp is tough and challenging. It is a three-day complete ...

For example, approvals for new drugs from ... in Series B funding to bolster research and development of its computer systems validation platform, Res_Q.