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.