CSV

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Related to software validation: Software verification

CSV

Abbreviation for continuous spontaneous ventilation.
References in periodicals archive ?
His latest book, Risk Based Software Validation -Ten easy Steps, relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.
However, for enterprise software validation processes, it is sometimes less common.
Carver's presentation will demonstrate how utilizing the advanced debug features of the Freescale Kinetis family of microcontrollers can accelerate the software validation process.
It supersedes "General Principles of Software Validation, Version 1.
For years, life sciences companies have struggled with the documentation burden associated with software validation.
Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.
A new resource has been released for small enterprises that manufacture medical devices to aid them understand software validation requirements that come from the FDA's General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
For years, organizations addressed software validation in a tactical, legalistic sense focusing on the required deliverables and documentation rather than looking holistically at regulatory intent and leveraging validation as a business advantage rather than a regulatory burden.
The upgraded system is in full compliance with 21 CFR Part 11 and includes full IQ/QQ validation as well as GAMP-4 software validation.
Understanding the work process simulated by testing is key to the performance qualification portion of computer software validation.

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