E-records integrity requirements /Orlando López.

By:

López, Orlando [Author]

Material type: Text

text

Media type:

computer

Carrier type:

online resource

ISBN:

9781685077266

Other title:

Requirements of e-Records Integrity

Subject(s):

Genre/Form:

Electronic Books.

LOC classification:

RM301 .E743 2022

Online resources:

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Available additional physical forms:

Subject: "The worldwide medicines' manufacturing practices regulations depend heavily on reliable data and records. The information properly recorded is the basis for manufacturers to assure the regulatory authorities of product identity, strengths, purity, and safety. The collected electronic records (e-records) also demonstrate that the manufacturing process adheres to the CGMP, including instructions. An element of reliable records is the integrity of such records. For the relevant stakeholders, such unauthorized alterations will be catalogued that the system is without the proper data integrity (DI) controls and would be deemed a noticeable deficiency. As a state or condition, e-records integrity is a measure of the validity and fidelity of related data. Based on the Universal Electronic Records Management (ERM) Requirements, Version 2.03 published by the National Archives and Records Administration (NARA), this book covers the requirements applicable to DI in the medicines' manufacturing practices regulations, pharmaceutical and biotechnological. This book presents the bounded characterization of e-records handling systems. The reader will have a reference of over fifty-three requirements that need to be agreed upon between the relevant stakeholders."--

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Holdings
Item type	Current library	Collection	Call number	URL	Status	Date due	Barcode
Online Book (LOGIN USING YOUR MY CIU LOGIN AND PASSWORD)	G. Allen Fleece Library ONLINE	Non-fiction	RM301.25 (Browse shelf(Opens below))	Link to resource	Available		on1305845639

Includes bibliographies and index.

"The worldwide medicines' manufacturing practices regulations depend heavily on reliable data and records. The information properly recorded is the basis for manufacturers to assure the regulatory authorities of product identity, strengths, purity, and safety. The collected electronic records (e-records) also demonstrate that the manufacturing process adheres to the CGMP, including instructions. An element of reliable records is the integrity of such records. For the relevant stakeholders, such unauthorized alterations will be catalogued that the system is without the proper data integrity (DI) controls and would be deemed a noticeable deficiency. As a state or condition, e-records integrity is a measure of the validity and fidelity of related data. Based on the Universal Electronic Records Management (ERM) Requirements, Version 2.03 published by the National Archives and Records Administration (NARA), this book covers the requirements applicable to DI in the medicines' manufacturing practices regulations, pharmaceutical and biotechnological. This book presents the bounded characterization of e-records handling systems. The reader will have a reference of over fifty-three requirements that need to be agreed upon between the relevant stakeholders."--

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