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Author:
Publisher: BRILL
ISBN: 9004484515
Category : Language Arts & Disciplines
Languages : en
Pages : 275
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Book Description
User manuals, reference guides, project documentation, equipment specifications and other technical documents are increasingly subjected to high quality standards. However, it is not clear whether research efforts are keeping pace with this increasing importance of documentation quality. This volume includes studies from researchers as well as practitioners, exemplifying three approaches towards document quality: • Product-orientation, with an eye for usability in various manifestations such as tutorials, concept definitions, tools for users of documentation to find information, methods of eliciting user feedback, and cultural differences; • Process-orientation, in which the quality of technical documentation is regarded as an outgrowth of a process involving sub-steps such as storyboarding, pre-testing and use of automation tools in writing and producing documents; • Professional orientation, in which attention is focused on those who create technical documentation. The volume will be of interest to a broad audience of writers, managers and trainers with technical and non-technical backgrounds, such as: quality managers; communication managers; technical communicators; trainers in computer usage; teachers, researchers and students of (technical) communication.
Author:
Publisher: BRILL
ISBN: 9004484515
Category : Language Arts & Disciplines
Languages : en
Pages : 275
Get Book
Book Description
User manuals, reference guides, project documentation, equipment specifications and other technical documents are increasingly subjected to high quality standards. However, it is not clear whether research efforts are keeping pace with this increasing importance of documentation quality. This volume includes studies from researchers as well as practitioners, exemplifying three approaches towards document quality: • Product-orientation, with an eye for usability in various manifestations such as tutorials, concept definitions, tools for users of documentation to find information, methods of eliciting user feedback, and cultural differences; • Process-orientation, in which the quality of technical documentation is regarded as an outgrowth of a process involving sub-steps such as storyboarding, pre-testing and use of automation tools in writing and producing documents; • Professional orientation, in which attention is focused on those who create technical documentation. The volume will be of interest to a broad audience of writers, managers and trainers with technical and non-technical backgrounds, such as: quality managers; communication managers; technical communicators; trainers in computer usage; teachers, researchers and students of (technical) communication.
Author: Andrew J. Marlow
Publisher:
ISBN: 9781873407097
Category : Quality control
Languages : en
Pages : 47
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Book Description
Quality Control for Technical Documentation has been written primarily for practising technical communicators, but might equally be useful to the student serious about pursuing a career in technical documentation, or engineers and programmers looking to embrace a change of vocation in whole or in part. The purpose of this book is to foster the idea that quality management should be an integral part of every technical documentation project. Without teaching any particular philosophy, the book introduces the technical communicator to a variety of approaches to quality control. It discusses techniques and procedures that can help the technical communicator formulate a programme designed to improve the quality of technical documentation. There are chapters on an introduction to quality management systems, defining a strategy for quality control, the review process and quality assessment.
Author: United States. Environmental Protection Agency. Office of Water
Publisher:
ISBN:
Category : Toxicology
Languages : en
Pages : 344
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Book Description
Author:
Publisher: DIANE Publishing
ISBN: 1428965769
Category :
Languages : en
Pages : 239
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Book Description
Author:
Publisher:
ISBN:
Category : Agricultural pollution
Languages : en
Pages : 326
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Book Description
Author:
Publisher: DIANE Publishing
ISBN: 1428901132
Category : Air
Languages : en
Pages : 65
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Book Description
Author: British Standards Institute Staff
Publisher:
ISBN: 9780580384813
Category :
Languages : en
Pages : 24
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Book Description
Quality control, Handbooks, Technical documents, Documents, Management, Quality assurance systems, Quality, Quality assurance
Author: John J. Tobin
Publisher: John Wiley & Sons
ISBN: 3527333266
Category : Science
Languages : en
Pages : 341
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Book Description
Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.
Author:
Publisher: DIANE Publishing
ISBN: 1428902139
Category :
Languages : en
Pages : 201
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Book Description
Author: Stephanie L. Skipper
Publisher: Quality Press
ISBN: 1953079504
Category : Business & Economics
Languages : en
Pages : 159
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Book Description
This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance. The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle. A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and data Sample documents are included in the appendixes of this book to help clarify explanations. This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.