21 CFR Part 11 PDF Download
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Author: Orlando López
Publisher: CRC Press
ISBN: 1135488754
Category : Medical
Languages : en
Pages : 287
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Book Description
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 such as encryption and digital signatures and places
Author: Orlando López
Publisher: CRC Press
ISBN: 1135488754
Category : Medical
Languages : en
Pages : 287
Get Book Here
Book Description
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 such as encryption and digital signatures and places
Author: Janet Gough
Publisher: John Wiley & Sons
ISBN: 0470597496
Category : Technology & Engineering
Languages : en
Pages : 486
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Book Description
The accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment’s notice. Written in a user-friendly Q&A style for quick reference, Managing the Documentation Maze provides answers to 750 questions the authors encounter frequently in their roles as consultants and trainers. In simple terms, this handy guide breaks down the key components that facilitate successful document management, and shows why it needs to be a core discipline in the industry with information on: Compliance with regulations in pharmaceutical, biological, and device record keeping Electronic systems, hybrid systems, and the entire scope of documentation that companies must manage How to write and edit documents that meet regulatory compliance Making the transition to an electronic system, including how to validate and document the process Anyone responsible for managing documents in the health field will find this book to be a trusted partner in unraveling the bureaucratic web of confusion, while it initiates a plan on how to put an effective, lasting system in place—one that will stand up to any type of scrutiny.
Author: Barry Leonard
Publisher: DIANE Publishing
ISBN: 143798746X
Category : Technology & Engineering
Languages : en
Pages : 476
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Book Description
This guidance will assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find info. that will help them identify hazards that are associated with their products, and help them formulate control strategies. It will help consumers understand commercial seafood safety in terms of hazards and their controls. It does not specifically address safe handling practices by consumers or by retail estab., although the concepts contained in this guidance are applicable to both. This guidance will serve as a tool to be used by fed. and state regulatory officials in the evaluation of HACCP plans for fish and fishery products. Illustrations. This is a print on demand report.
Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249
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Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g
Author: Gladys Q. Ramey
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 112
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Book Description
Author: Prashant Johri
Publisher: Academic Press
ISBN: 0323902413
Category : Technology & Engineering
Languages : en
Pages : 616
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Book Description
System Assurances: Modeling and Management updates on system assurance and performance methods using advanced analytics and understanding of software reliability growth modeling from today's debugging team's point-of-view, along with information on preventive and predictive maintenance and the efficient use of testing resources. The book presents the rapidly growing application areas of systems and software modeling, including intelligent synthetic characters, human-machine interface, menu generators, user acceptance analysis, picture archiving and software systems. Students, research scholars, academicians, scientists and industry practitioners will benefit from the book as it provides better insights into modern related global trends, issues and practices. - Provides software reliability modeling, simulation and optimization - Offers methodologies, tools and practical applications of reliability modeling and resources allocation - Presents cost modeling and optimization associated with complex systems
Author: David Nettleton
Publisher: CRC Press
ISBN: 9781135490133
Category : Medical
Languages : en
Pages : 384
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Book Description
The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system that will keep your organization in compliance. Covering Title 21 of the Code of Federal Regulations (CFR) Part 11 and the parallel, recently passed Title 45 CFR Parts 160, 162, and 164 of the Health Insurance Portability and Accountability Act (HIPAA), this book provides guidance for selecting, purchasing, installing, validating, and managing commercial off-the-shelf software for data collection and retention. It takes a number of years for industry standards for a new regulation to develop from dialog between companies and the regulating agency. These standards are in place for Part 11, which was passed into law in 1997. Healthcare providers who must implement electronic record keeping can learn how to best do it by understanding the parallel between the new HIPAA regulations and the industry standards for Part 11. Further, certain FDA-driven activities, such as patient record keeping in clinical trials, now must comply with the new HIPAA regs as well. To help companies achieve and maintain compliance, the authors cover audit trails, validation, documentation, training, and security and accountability. They discuss what the regulations say and what they mean. Compliance may be mandatory, but it also makes good business sense. Companies that are compliant will always be poised to move forward, and they will avoid the grief that comes from poor or faulty record keeping and documentation. This book gives you the tools you need to keep your company both compliant and competitive.
Author: James P. Agalloco
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 762
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Book Description
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Author:
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 656
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Book Description
Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.
Author:
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 1020
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Book Description
The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
