Author: Niall Richard Murphy
Publisher: "O'Reilly Media, Inc."
ISBN: 1491951176
Category :
Languages : en
Pages : 552
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Book Description
The overwhelming majority of a software system’s lifespan is spent in use, not in design or implementation. So, why does conventional wisdom insist that software engineers focus primarily on the design and development of large-scale computing systems? In this collection of essays and articles, key members of Google’s Site Reliability Team explain how and why their commitment to the entire lifecycle has enabled the company to successfully build, deploy, monitor, and maintain some of the largest software systems in the world. You’ll learn the principles and practices that enable Google engineers to make systems more scalable, reliable, and efficient—lessons directly applicable to your organization. This book is divided into four sections: Introduction—Learn what site reliability engineering is and why it differs from conventional IT industry practices Principles—Examine the patterns, behaviors, and areas of concern that influence the work of a site reliability engineer (SRE) Practices—Understand the theory and practice of an SRE’s day-to-day work: building and operating large distributed computing systems Management—Explore Google's best practices for training, communication, and meetings that your organization can use
Author: Orlando López
Publisher:
ISBN: 9781032339887
Category :
Languages : en
Pages : 0
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Book Description
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.
Author: R. D. McDowall
Publisher: Royal Society of Chemistry
ISBN: 178801281X
Category : Computers
Languages : en
Pages : 660
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Book Description
This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
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:
Publisher: Ispe Headquarters
ISBN: 9781931879392
Category : Technology & Engineering
Languages : en
Pages :
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309147824
Category : Computers
Languages : en
Pages : 179
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Book Description
As digital technologies are expanding the power and reach of research, they are also raising complex issues. These include complications in ensuring the validity of research data; standards that do not keep pace with the high rate of innovation; restrictions on data sharing that reduce the ability of researchers to verify results and build on previous research; and huge increases in the amount of data being generated, creating severe challenges in preserving that data for long-term use. Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age examines the consequences of the changes affecting research data with respect to three issues - integrity, accessibility, and stewardship-and finds a need for a new approach to the design and the management of research projects. The report recommends that all researchers receive appropriate training in the management of research data, and calls on researchers to make all research data, methods, and other information underlying results publicly accessible in a timely manner. The book also sees the stewardship of research data as a critical long-term task for the research enterprise and its stakeholders. Individual researchers, research institutions, research sponsors, professional societies, and journals involved in scientific, engineering, and medical research will find this book an essential guide to the principles affecting research data in the digital age.
Author: United States Government Accountability Office
Publisher: Lulu.com
ISBN: 0359541828
Category : Reference
Languages : en
Pages : 88
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Book Description
Policymakers and program managers are continually seeking ways to improve accountability in achieving an entity's mission. A key factor in improving accountability in achieving an entity's mission is to implement an effective internal control system. An effective internal control system helps an entity adapt to shifting environments, evolving demands, changing risks, and new priorities. As programs change and entities strive to improve operational processes and implement new technology, management continually evaluates its internal control system so that it is effective and updated when necessary. Section 3512 (c) and (d) of Title 31 of the United States Code (commonly known as the Federal Managers' Financial Integrity Act (FMFIA)) requires the Comptroller General to issue standards for internal control in the federal government.
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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Book Description
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author: Orlando Lopez
Publisher: CRC Press
ISBN: 1040083706
Category : Business & Economics
Languages : en
Pages : 262
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Book Description
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 requirements for computer systems.The purpose of Annex 11 is
Author: Anton Bespalov
Publisher: Springer Nature
ISBN: 3030336565
Category : Cardiology
Languages : en
Pages : 424
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Book Description
This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.
