عنوان

Pharmaceutical and medical devices manufacturing computer systems validation /

شابک

1315174618

شابک

1351704346

شابک

1351704354

شابک

9781315174617

شابک

9781351704342

شابک

9781351704359

شابک اشتباه

9781138041189 (hardback : alk. paper)

عنوان اصلي

Pharmaceutical and medical devices manufacturing computer systems validation /

نام عام مواد

[Book]

نام نخستين پديدآور

Orlando Lopez.

محل نشرو پخش و غیره

Boca Raton :

نام ناشر، پخش کننده و غيره

Taylor & Francis,

تاریخ نشرو بخش و غیره

[2018]

نام خاص و کميت اثر

1 online resource

متن يادداشت

Includes bibliographical references and index.

متن يادداشت

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.

بدون عنوان

0

متن يادداشت

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.

عنوان

Pharmaceutical and medical devices manufacturing computer systems validation

شماره استاندارد بين المللي کتاب و موسيقي

9781138041189

موضوع مستند نشده

Medical instruments and apparatus-- Design.

موضوع مستند نشده

Medical instruments and apparatus-- Quality control.

موضوع مستند نشده

Pharmaceutical industry-- Data processing.

موضوع مستند نشده

Computer Security.

موضوع مستند نشده

Computer Systems.

موضوع مستند نشده

Equipment and Supplies.

موضوع مستند نشده

Technology, Pharmaceutical-- methods.

موضوع مستند نشده

MEDICAL / Pharmacology

موضوع مستند نشده

Medical instruments and apparatus-- Design.

موضوع مستند نشده

Medical instruments and apparatus-- Quality control.

موضوع مستند نشده

Pharmaceutical industry-- Data processing.

موضوع مستند نشده

MED-- 071000

شماره

ويراست

شماره رده

شماره رده

مستند نام اشخاص تاييد نشده

López, Orlando

تاريخ عمليات

20200822160454.0

قواعد فهرست نويسي ( بخش توصيفي )

rda

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y