21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutica

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Author : Orlando López
Genre : Medical

Summary : Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies su

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Author : Orlando Lopez
Genre : Computers

Summary : Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirement

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Author : Orlando Lopez
Genre : Medical

Summary : 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

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Author : Siri H. Segalstad
Genre : Law

Summary : Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementa

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Author : Orlando Lopez
Genre : Business & Economics

Summary : 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 an

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Author : Orlando López
Genre : Business & Economics

Summary : 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

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Author : Orlando López
Genre : Medical

Summary : Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies su