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Image of - Pharmaceutical And Medical Devices Manufacturing Computer Systems Validation | Paperback
Pharmaceutical And Medical Devices Manufacturing Computer Systems Validation | Paperback

Pharmaceutical And Medical Devices Manufacturing Computer Systems Validation | Paperback

by Lopez O.

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 authoritys requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions.

Highlights

  • binding-icon

    9781032094700

    ISBN:

  • binding-icon

    Lopez O.

    Author:

  • binding-icon

    344

    Pages:

  • binding-icon

    390 gm

    Weight:

  • langauage-icon

    English

    Language:

  • date-icon

    2021

    Year:

  • edition-icon

    1st Edition

    Edition:

  • binding-icon

    Paperback

    Binding:

₹3104

₹3880

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 authoritys requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions.

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