عنوان
پدید آورنده
موضوع
رده
کتابخانه
محل استقرار
INTERNATIONAL STANDARD BOOK NUMBER
(Number (ISBN
9781482243635
Erroneous ISBN
9781482243628
NATIONAL BIBLIOGRAPHY NUMBER
Number
dltt
TITLE AND STATEMENT OF RESPONSIBILITY
Title Proper
EU Annex 11 guide to computer validation compliance for the Worldwide Health Agency GMP
General Material Designation
[Book]
First Statement of Responsibility
Orlando López ; contributors, R.D. McDowall [and three others].
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
1 online resource :
Other Physical Details
illustrations
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references.
SUMMARY OR ABSTRACT
Text of Note
The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems. This book supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program. It details a practical approach to increase efficiency and to ensure that software development and maintenance are achieved correctly. Examples from laboratory, clinical, and manufacturing computer systems are included as well as a discussion of electronic record integrity associated with stored information. Comparisons to the Annex 11 with key worldwide computer systems regulations and guidelines, including U.S. Food and Drug Administration, Canada, Australia TGA, PIC/S, and China FDA are shown. --
TOPICAL NAME USED AS SUBJECT
Computer security.
Computer software-- Validation.
PERSONAL NAME - PRIMARY RESPONSIBILITY
López, Orlando
PERSONAL NAME - ALTERNATIVE RESPONSIBILITY
McDowall, R. D.
CORPORATE BODY NAME - ALTERNATIVE RESPONSIBILITY
Books24x7, Inc.
ORIGINATING SOURCE
Date of Transaction
20150804134500.0
Cataloguing Rules (Descriptive Conventions))
pn
ELECTRONIC LOCATION AND ACCESS
Electronic name
مطالعه متن کتاب [Book]
Y
