21 CFR Part 11: How Does it Affect Laboratory Automation Software Developers?

نویسندگان

چکیده

برای دانلود باید عضویت طلایی داشته باشید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

My continuing adventure with 21 CFR Part 11 - the evolution of Zymark's compliance

A renewed focus has been given to the 3-year-old regulation 21 CFR Part 11, Electronic Records and Electronic Signatures. This paper gives a chronology of the process of an equipment vendor, Zymark Corporation, validating laboratory automation equipment for compliance to the regulation 21 CFR Part 11. Zymark's Tablet Processing Workstation II (TPW) and Prelude are the instruments chronicled. Th...

متن کامل

D Addressing 21 CFR Part 11 Requirements with an Automated Configuration Audit

by David Deitz This article describes how configuration software changes are commonly tracked and managed today using “paperbased” configuration audit trails, the shortcomings of the paper-based solutions, and a new automated computer-based configuration audit trail that addresses the shortcomings of the traditional paper-based solutions. Introduction esigning and implementing process control s...

متن کامل

Globalisation: what is it and how does it affect health?

The term "globalisation" tends to be misused and overused. We need greater clarity in our understanding of the globalisation process, including the distinct changes involved and their relation to human health. The health impacts of globalisation are simultaneously positive and negative, varying according to factors such as geographical location, sex, age, ethnic origin, education level, and soc...

متن کامل

How free software developers work

This configuration leads to questions on the characteristics of the collective action that enables the transition from individual voluntary commitments that are potentially volatile and unstable to the completion of a collective production that involves continuity and sustainability. The production of free software cannot be considered the contingent result of a spontaneous convergence of indiv...

متن کامل

How Does Monetary Policy Affect Household Income Distribution?

Over the last decades the research on monetary policy has largely concentrated on the impact of monetary authorities’ decisions on inflation and the fine-tuning of the macroeconomic, so that distributional effects of monetary policy which are non-trivial has been ignored. A view that has become increasingly popular since the financial crisis 2008 is that expansionary monetary policy can exacerb...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

ژورنال

عنوان ژورنال: JALA: Journal of the Association for Laboratory Automation

سال: 2002

ISSN: 1535-5535

DOI: 10.1016/s1535-5535-04-00197-2