عنوان

Pharmaceutical and medical devices manufacturing computer systems validation /

(Number (ISBN

1315174618

(Number (ISBN

1351704346

(Number (ISBN

1351704354

(Number (ISBN

9781315174617

(Number (ISBN

9781351704342

(Number (ISBN

9781351704359

Erroneous ISBN

9781138041189 (hardback : alk. paper)

Title Proper

Pharmaceutical and medical devices manufacturing computer systems validation /

General Material Designation

[Book]

First Statement of Responsibility

Orlando Lopez.

Place of Publication, Distribution, etc.

Boca Raton :

Name of Publisher, Distributor, etc.

Taylor & Francis,

Date of Publication, Distribution, etc.

[2018]

Specific Material Designation and Extent of Item

1 online resource

Text of Note

Includes bibliographical references and index.

Text of Note

What is computer systems validation (CSV)? -- CGMP regulatory requirements for production computer systems -- Maxims in CSV -- General CSV principles -- System lifecycle (SLC) -- SLC documentation (cover the data integrity in documentation) -- Management of the computer system requirements -- Risk management based validation -- CSV plans and schedules -- Project management, SLC and production computers validation -- Computer systems operational life -- Suppliers and service providers -- Trustworthy computer systems -- Control of data and record -- Technologies supporting integrity of electronic records -- Infrastructure qualification overview -- Remediation projects -- Production CSV program organization -- Alignment between system and data lifecycle updated -- Digital date and time stamps -- New technologies and critical processes (access management; big data; clouds environments; IoT; SLAs, wireless) -- All together.

0

Text of Note

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement. Compliance is a state of being in accordance with established guidelines or specifications. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems are correctly achieved.

Title

Pharmaceutical and medical devices manufacturing computer systems validation

International Standard Book Number

9781138041189

Medical instruments and apparatus-- Design.

Medical instruments and apparatus-- Quality control.

Pharmaceutical industry-- Data processing.

Computer Security.

Computer Systems.

Equipment and Supplies.

Technology, Pharmaceutical-- methods.

MEDICAL / Pharmacology

Medical instruments and apparatus-- Design.

Medical instruments and apparatus-- Quality control.

Pharmaceutical industry-- Data processing.

MED-- 071000

Number

Edition

Class number

Class number

López, Orlando

Date of Transaction

20200822160454.0

Cataloguing Rules (Descriptive Conventions))

rda

Electronic name

[Book]

Y