CSV

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CSV

Abbreviation for continuous spontaneous ventilation.
Medical Dictionary for the Health Professions and Nursing © Farlex 2012
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Robert Marohn is Director of Computer System Validation in Quality Engineering at Kite Pharma, a leader in engineered T cell therapy.
Computer system validation following GAMP guidelines requires users and suppliers to work in concert so that responsibilities regarding the validation process are understood.
The new service features solutions for computer system validation (CSV) as well as Electronic records/electronic signatures (ER/ES) in drug application procedure.
Cetan Technologies, formerly PharmComm, specializes in Computer System Validation (CSV).
TABLE 1: Major Data Integrity Elements Coverage in MHRA and FDA Guidance Documents Data Integrity Elements MHRA FDA Meta-data X X Raw/Original data X X Data Governance X X (1) Data Lifecycle (retention, X X archival and Back-up) Computer System Access X X Computer System Transactions X Computer System Validation X X Electronic Signatures X X Audit Trails X X Data Review X X Contemporaneous Recording of X X Actions Control of blank forms and X X templates Use of Samples for System X Suitability Reprocessing of X Chromatography Data
This document is intended to provide the reader with an overview of the issues and topics associated with computer system validation in general and specifically in reference to system solutions from METTLER TOLEDO.
They provide supplier audit services, on a global basis and their Computer Compliance Advisors, Computer System Validation Project Managers and Computer System Validation Consultants have extensive experience in all technologies related to the Life Sciences industry.
Zifo provides Clinical Data Solutions, Discovery & Lab Informatics Solutions, Computer System Validation and Consulting Services from global offices across US, UK, Europe, India and Japan.

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