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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Other manufacturing technologies > Precision instruments manufacture
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Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation (Hardcover)
Loot Price: R4,032
Discovery Miles 40 320
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Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation (Hardcover)
Expected to ship within 12 - 17 working days
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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.
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