Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

Author: Orlando Lopez

Publisher: Taylor & Francis

Published: 2018-10-02

Total Pages: 232

ISBN-13: 1351704346

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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.

Pharmaceutical Computer Systems Validation
Pharmaceutical Computer Systems Validation

Author: Guy Wingate

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 773

ISBN-13: 1420088955

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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

Author: Stephen Robert Goldman

Publisher: 1st Book Library

Published: 2003

Total Pages: 480

ISBN-13:

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This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib

GAMP 5
GAMP 5

Author: Sion Wyn

Publisher:

Published: 2008

Total Pages: 0

ISBN-13: 9781931879613

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GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.

Pharmaceutical and Medical Device Validation by Experimental Design
Pharmaceutical and Medical Device Validation by Experimental Design

Author: Lynn D Torbeck

Publisher: CRC Press

Published: 2007-06-26

Total Pages: 272

ISBN-13: 1420055704

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This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational ap

Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry
Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry

Author: Eugenia Gabriela Carrillo-Cedillo

Publisher:

Published: 2022

Total Pages:

ISBN-13: 9781799896142

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"This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients"--

Medical Device Regulations
Medical Device Regulations

Author: Michael Cheng

Publisher: World Health Organization

Published: 2003-09-16

Total Pages: 54

ISBN-13: 9241546182

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The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Validation Standard Operating Procedures
Validation Standard Operating Procedures

Author: Syed Imtiaz Haider

Publisher: CRC Press

Published: 2006-05-30

Total Pages: 1144

ISBN-13: 1420009419

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Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations
Data Integrity in Pharmaceutical and Medical Devices Regulation Operations

Author: Orlando López

Publisher:

Published: 2022-06

Total Pages: 0

ISBN-13: 9781032339887

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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 development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.