عنوان
پدید آورنده
موضوع
رده
کتابخانه
محل استقرار
INTERNATIONAL STANDARD BOOK NUMBER
(Number (ISBN
1574911333
NATIONAL BIBLIOGRAPHY NUMBER
Number
b398478
TITLE AND STATEMENT OF RESPONSIBILITY
Title Proper
Validation of computerized analytical and networked systems /
General Material Designation
[Book]
First Statement of Responsibility
Ludwig Huber.
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Englewood, CO :
Name of Publisher, Distributor, etc.
Interpharm Press,
Date of Publication, Distribution, etc.
c2002.
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
viii, 228 p. :
Other Physical Details
ill. ;
Dimensions
26 cm.
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references (p. 201-210) and index.
CONTENTS NOTE
Text of Note
Regulations and standards -- Terminology -- Design qualification -- Vendor assessment -- Validation during development -- Installation qualification -- Operational qualification -- Maintenance and ongoing performance qualification -- Validation of macros and spreadsheet programs -- Validation of networked systems -- Compliance with electronic records and signatures (21 cfr part 11) -- Operational compliance of legacy systems -- Audits.
0
TOPICAL NAME USED AS SUBJECT
Pharmaceutical industry-- Data processing-- Quality control.
Pharmaceutical technology-- Automation-- Quality control.
Computer-Aided Design-- standards.
Drug Industry-- standards.
Laboratories-- standards.
Quality Control.
Software Validation.
PERSONAL NAME - PRIMARY RESPONSIBILITY
Huber, Ludwig,1948-
ORIGINATING SOURCE
Date of Transaction
20030204000000.0
ELECTRONIC LOCATION AND ACCESS
Electronic name
مطالعه متن کتاب [Book]
Y
