عنوان

Validation of chromatography data systems :

شابک

1849736626

شابک

9781849736626

شابک اشتباه

9781782624073

شابک اشتباه

9781782629801

شماره

dltt

عنوان اصلي

Validation of chromatography data systems :

نام عام مواد

[Book]

ساير اطلاعات عنواني

ensuring data integrity, meeting business and regulatory requirements /

نام نخستين پديدآور

R. D. McDowall

وضعيت ويراست

2nd edition

نام خاص و کميت اثر

xliv, 733 pages :

ساير جزييات

illustrations ;

ابعاد

24 cm

عنوان فروست

RSC Chromatography Monographs

مشخصه جلد

No. 20

شاپا ي ISSN فروست

1757-7055

متن يادداشت

Includes bibliographical references and index

متن يادداشت

How to use this book -- What is a CDS? The past, present and future -- Laboratory informatics and the role of a CDS -- Applicable GXP regulations and guidance for CSV -- Concepts of computer validation -- Understanding software categories and system life cycles -- Ensuring data integrity for chromatography data systems -- CDS validation: managing system risk -- Working electronically and using electronic signatures -- Writing the user and system requirements -- Controlling the validation -- System selection -- Assessing the CDS supplier -- Negotiating the contract and purchasing the system -- Planning the installation of the system -- CSV risk management requirements level assessment -- Importance of the traceability matrix -- Writing configuration specifications -- Writing the technical specification -- Installing and integrating system components -- Designing the user acceptance test suite -- Writing test scripts and test cases -- Executing test scripts and reporting the results -- User training and system documentation -- IT support for a CDS -- System description -- Defining electronic records and raw data for a CDS -- Writing the validation summary report -- Integration in a regulated environment -- User account management -- Incident and problem management -- Change control and configuration management -- Periodic review of the CDS -- CDS records retention -- CDS system retirement -- CDS data migration -- Retrospective validation

بدون عنوان

0

موضوع مستند نشده

Chromatographic analysis

موضوع مستند نشده

Computer software-- Validation

شماره رده

نشانه اثر

مستند نام اشخاص تاييد نشده

McDowall, R. D.

تاريخ عمليات

20170718045511.0

قواعد فهرست نويسي ( بخش توصيفي )

rda

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y