Validating Automated Manufacturing and Labratory applications, Guy Wingate

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Item specifics

Condition
Like New
A book in excellent condition. Cover is shiny and undamaged, and the dust jacket is included for hard covers. No missing or damaged pages, no creases or tears, and no underlining/highlighting of text or writing in the margins. May be very minimal identifying marks on the inside cover. Very minimal wear and tear. See all condition definitionsopens in a new window or tab
Seller Notes
“Nice condition”
ISBN
9781574910377
Category

About this product

Product Identifiers

Publisher
CRC Press LLC
ISBN-10
157491037X
ISBN-13
9781574910377
eBay Product ID (ePID)
7038656298

Product Key Features

Number of Pages
592 Pages
Language
English
Publication Name
Validating Automated Manufacturing and Laboratory Applications : Putting Principles Into Practice
Subject
Automation, Pharmacology
Publication Year
1997
Type
Textbook
Subject Area
Technology & Engineering, Medical
Author
Guy Wingate, Steven Strauss
Format
Hardcover

Dimensions

Item Height
1.5 in
Item Weight
48.4 Oz
Item Length
1 in
Item Width
0.7 in

Additional Product Features

Intended Audience
Scholarly & Professional
LCCN
98-007662
Dewey Edition
21
Illustrated
Yes
Dewey Decimal
615/.19/00285
Table Of Content
Chapters include: o History of Validation o Organization o Validating Automation Systems o Validation Strategies o Ongoing Support o Working Relationships o Validation Capability o Topical Issues Case Studies: o Validating Instrumentation o Validating Programmable Logic Controllers (PLC) o Validating Industrial Personal Computer Systems (IPC) o Validating Supervisory Control and Data Acquisition Systems (SCADA) o Validating Distributed Control Systems (DCS) o Validating Manufacturing Execution Systems (MES) o Validating Manufacturing Resource Planning Systems (MRP II) o Validating Maintenance and Calibration Computer Systems o Validating Engineering Management Systems (EMS) o Validating Building Management Systems (BMS) o Validating Laboratory Automation Systems o Validating Laboratory Information Management Systems (LIMS) o Validating Electronic Documentation Management Systems (EDMS) o Validating Electronic Batch Record Systems (EBRS) o Validating Automated Medical Devices
Synopsis
Since 1994, the German GMA-NAMUR, German APV, ISPE-Baseline, OECD, UK GAMP Forum, UK IQA-PQG, US DIA, ISPE, and PDA initiatives have supplemented the regulations governing the validation of automated systems with high-level guidelines. The result has been a broadly accepted industry framework for validating automation systems. It includes Good Automated Manufacturing Practice (GAMP), Good Automated Laboratory Practice (GALP), and Good Information Technology Practice (GITP). This book deals directly with project problems and their resolutions based upon the experience of established industry practitioners. The first part introduces the principles of good practice and why validation is needed, concluding with the Ten Commandments for Validating Automation. The second part presents a comprehensive selection of case studies (provided by industry experts)., Since 1994, the German GMA-NAMUR, German APV, ISPE-Baseline, OECD, UK GAMP Forum, UK IQA-PQG, US DIA, ISPE, and PDA initiatives have supplemented the regulations governing the validation of automated systems with high-level guidelines. The result has been a broadly accepted industry framework for validating automation systems. This book deals directly with project problems and their resolutions based upon the experience of established industry practitioners. It introduces the principles of good practice and why validation is needed, presents a comprehensive selection of case studies provided by industry experts, and concludes with the Ten Commandments for Validating Automation.
LC Classification Number
RS122.2.W56 1997

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Purveyors of Stuff

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Purveyors of Stuff started back in the 1950s and 1960s when my Dad and I used to pickup antiques and used items on trash day. That was my favorite time with him,Dad was way ahead of his time. He ...
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