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Computer system validation following GAMP guidelines requires users and suppliers to work in concert so that responsibilities regarding the validation process are understood.
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.
The regulator is also organizing joint workshops with FDA in different cities to exchange updates in various aspects of GMPs like process validation, computer system validation etc.
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.
Perhaps it is too early to suggest to the GAMP Forum that they could get it right in GAMP 6: a general introduction on the principles of computer system validation (CSV) for all systems.
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.
Examining the two studies, we found that, ultimately, a computer system validation in clinical trials is possible only when a standardized work process has been used to test the technology," stated Ms.
IS YOUR ORGANIZATION READY FOR an inspection of your Computer System Validation program?
Patrick Den Boer is a recognized expert in the Pharmaceutical Industry in areas including Computer System Validation, PDMA Compliance, Sample Accountability, Sales Force Automation, Aggregate Spend Management, Warehousing, Fulfillment, and Pharmacy Operations.
During her presentation, she presented two case studies that described approaches to computer system validation.
This acquisition allows us to add a mid-Atlantic presence to our three New England offices while still offering the highest quality information technology and computer system validation services to our clients.

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