Computer Systems Validation in Clinical Research
Author: ACDM/PSI Working Party on Computer Systems Validation
Publisher:
Published: 1997
Total Pages: 84
ISBN-13:
DOWNLOAD EBOOKRead and Download eBook Full
Author: ACDM/PSI Working Party on Computer Systems Validation
Publisher:
Published: 1997
Total Pages: 84
ISBN-13:
DOWNLOAD EBOOKAuthor: Mindy Allport-Settle
Publisher: PharmaLogika Books
Published: 2021-03-31
Total Pages: 0
ISBN-13: 9781937258252
DOWNLOAD EBOOKAuthor: Guy Wingate
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 773
ISBN-13: 1420088955
DOWNLOAD EBOOKThoroughly 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.
Author: Ludwig Huber
Publisher: CRC Press
Published: 2023-04-28
Total Pages: 268
ISBN-13: 1000948226
DOWNLOAD EBOOKValidation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details. International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
Author: Richard Chamberlain
Publisher:
Published: 1994
Total Pages: 0
ISBN-13: 9780963148902
DOWNLOAD EBOOKThis book presents the topic of computer systems validation in a regulated environment in a manner that the layman can understand. It explains the relationship of validation to the implementation of computer systems. A step-by-step plan for implementing validation procedures in almost any environment is given. The chapters cover preparing validation protocols, writing & implementing Standard Operating Procedures, testing systems, managing files, preparing documentation, conducting audits & inspections, & operating in a validated environment. One of the appendices to the book includes 16 draft Standard Operating Procedures. The book comes with two floppy disks (3.5 & 5.25 inch) each containing the draft Standard Operating Procedures & the forms introduced in the book in both ASCII & WordPerfect formats. The book is essential for management, quality assurance, scientists, & information management personnel in both of these industries.
Author:
Publisher:
Published: 1993
Total Pages:
ISBN-13:
DOWNLOAD EBOOKAuthor: Pieter Kubben
Publisher: Springer
Published: 2018-12-21
Total Pages: 219
ISBN-13: 3319997130
DOWNLOAD EBOOKThis open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.
Author: Carol I. Matthews
Publisher: SAS Institute
Published: 2008
Total Pages: 229
ISBN-13: 1599941287
DOWNLOAD EBOOKThis indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration.
Author: Phillip A. Carson
Publisher: Royal Society of Chemistry
Published: 2007
Total Pages: 657
ISBN-13: 0854048340
DOWNLOAD EBOOKProvides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.
Author: Karl-Heinz Schriever
Publisher: Walter de Gruyter GmbH & Co KG
Published: 2014-10-02
Total Pages: 193
ISBN-13: 3110381591
DOWNLOAD EBOOKEstablishing ethical and privacy protection aspects in scientific research, especially in medical research, has a long history. Medical data are usually more sensible than other personal data and require therefore an even higher degree of protection than other personal data. In recent research projects genetic evaluations become more and more important and trigger thereby new and continuing activities in the context of data protection. Genetic data as a subset of medical data are the most sensible category of personal data and require therefore the highest degree of data protection. The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Technical requirements and aspects of data protection including pseudonymization and anonymization procedures taking into account ethics committees requirements as well as the underlying legal framework are also presented. Without any exception, all principles and methods presented are best practices, repeatedly applied in different clinical environments and by no means theoretical considerations.