eBook: Requirements of E-Records Integrity (DRM PDF)
 
電子書格式: DRM PDF
作者: Orlando Lopez 
系列: Research Methodology and Data Analysis
分類: Databases ,
Computer science  
書城編號: 24967120


售價: $2990.00

購買後立即進貨, 約需 1-4 天

 
 
製造商: Nova Science Publishers, Inc.
出版日期: 2022/03/03
頁數: 327
ISBN: 9781685077266
 
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商品簡介
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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Orlando Lopez 作者作品表

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E-Records Integrity Requirements (Hardcover)

eBook: Requirements of E-Records Integrity (DRM PDF)

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Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation (Hardcover)

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