عنوان
پدید آورنده
موضوع
رده
کتابخانه
محل استقرار
INTERNATIONAL STANDARD BOOK NUMBER
(Number (ISBN
085404969X
(Number (ISBN
9780854049691
NATIONAL BIBLIOGRAPHY NUMBER
Number
b550464
TITLE AND STATEMENT OF RESPONSIBILITY
Title Proper
Validation of chromatography data systems
General Material Designation
[Book]
First Statement of Responsibility
R.D. McDowall.
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Cambridge
Name of Publisher, Distributor, etc.
Royal Society of Chemistry
Date of Publication, Distribution, etc.
2005
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
200 pages ; 24 cm
CONTENTS NOTE
Text of Note
How to use this book; Introduction to Chromatography Data Systems; Regulatory Requirements for CDS Validation; Concepts of Computer Validation; CDS Validation: Managing System Risk; Process Redesign to Exploit the Tangible Benefits of Electronic Signatures with a CDS; Writing the User Requirements Specification (URS); Controlling the Work: The Validation Plan; System Selection; Auditing the CDS Vendor; Contract, Purchase Order and Planning the Installation; Risk Assessment and Requirements Traceability; Installation Qualification and Operational Qualification (IQ and OQ); Performance Qualification (PQ) or End User Testing; User Training and System Documentation; IT Support of the System; System Description; Validation Summary Report; Defining Electronic Records for a CDS; Maintaining the Validation Status during Operational Life; Periodic Review of the CDS; Records Retention; CDS Data Migration; CDS System Retirement; Retrospective Validation; References;
TOPICAL NAME USED AS SUBJECT
Chromatographic analysis.
Computer software -- Validation.
PERSONAL NAME - PRIMARY RESPONSIBILITY
R.D. McDowall.
PERSONAL NAME - ALTERNATIVE RESPONSIBILITY
R D McDowall
Royal Society of Chemistry (Great Britain)
ELECTRONIC LOCATION AND ACCESS
Electronic name
مطالعه متن کتاب [Book]
Y
