21 CFR Part 11

21 CFR Part 11

Orlando Lopez

122,04 €
IVA incluido
Disponible
Editorial:
Taylor & Francis Ltd
Año de edición:
2019
Materia
Química
ISBN:
9780367394592
122,04 €
IVA incluido
Disponible

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Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance.

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Otros libros del autor

  • Implementation of a Data Reliability Program
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    Ensuring the accuracy, completeness, and accessibility of data is paramount in today’s data-driven landscape. This book is a comprehensive guide that aids readers in effectively managing data and e-records’ reliability vulnerabilities while maintaining crucial compliance standards.The data reliability program applies to various industries. However, the author uses the medicinal...
  • Data Integrity in Pharmaceutical and Medical Devices Regulation Operations
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    Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems deve...
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  • Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
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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 complian...
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  • Ensuring the Integrity of Electronic Health Records
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    Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to ...
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  • Ensuring the Integrity of Electronic Health Records
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    Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to ...