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Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
Af: Orlando Lopez Engelsk Paperback
SPAR
kr 30
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
Af: Orlando Lopez Engelsk Paperback

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 (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions.





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 is correctly achieved.

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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 (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions.





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 is correctly achieved.

Produktdetaljer
Sprog: Engelsk
Sider: 344
ISBN-13: 9781032094700
Indbinding: Paperback
Udgave:
ISBN-10: 1032094702
Udg. Dato: 30 jun 2021
Længde: 32mm
Bredde: 175mm
Højde: 254mm
Oplagsdato: 30 jun 2021
Forfatter(e): Orlando Lopez
Forfatter(e) Orlando Lopez


Kategori Farmaceutisk kemi og teknologi


Sprog Engelsk


Indbinding Paperback


Sider 344


Udgave


Længde 32mm


Bredde 175mm


Højde 254mm


Udg. Dato 30 jun 2021


Oplagsdato 30 jun 2021

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