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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.
Giving comprehensive, soup-to-nuts coverage of database administration, this guide is written from a platform-independent viewpoint, emphasizing best practices.
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.
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 it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.
This widely adopted textbook provides the essential content and skill-building tools for teaching the responsible conduct of scientific research. Scientific Integrity covers the breadth of concerns faced by scientists: protection of animal and human experimental subjects, scientific publication, intellectual property, conflict of interest, collaboration, record keeping, mentoring, and the social and ethical responsibilities of scientists. Learning activities and resources designed to elucidate the principles of Scientific Integrity include Dozens of highly relevant, interactive case studies for discussion in class or online Numerous print and online resources covering the newest research guidelines, regulations, mandates and policies Discussion questions, role-playing exercises, and survey tools to promote critical thought Documents including published rules of conduct, sample experimentation protocols, and patent applications The new edition of Scientific Integrity responds to significant recent changes—new mandates, policies, laws, and other developments—in the field of responsible conduct of research. Dr. Macrina plants the seeds of awareness of existing, changing, and emerging standards in scientific conduct and provides the tools to promote critical thinking in the use of that information. Scientific Integrity is the original turnkey text to guide the next generations of scientists as well as practicing researchers in the essential skills and approaches for the responsible conduct of science.
Complete Guide to Federal and State Garnishment provides much-needed clarity when the federal and state laws appear to conflict. You'll find plain-English explanations of the laws and how they interact, as well as the specific steps you and your staff need to take to respond to the order properly. Numerous detailed examples and mathematical calculations make it easy to apply the law under different scenarios. Written by Amorette Nelson Bryant, who was recently appointed by the Uniform Law Commission as an observer for the Drafting Committee on a Wage Garnishment Act and was a past chair of both the APA GATF Child Support Subcommittee and Garnishment Subcommittee, Complete Guide to Federal and State Garnishment brings the payroll professional up-to-date on the latest federal and state laws and regulations affecting this ever-changing area. It is your one-stop source for answers to critical questions, such as: Does the amount exempt from garnishment change when the minimum wage goes up? How do I determine the wages to which the garnishment applies? If an employee is subject to more than one garnishment, which has priority? Which state's rules do I use when I receive a child support order sent from another state? State or federal law - which applies for creditor garnishment and support? Are there alternatives to remitting withheld child support via EFT/EDI? How do I handle garnishments when employees are paid a draw against salary? Previous Edition: Complete Guide to Federal and State Garnishment, 2018 Edition, ISBN 9781454884255¿
When doing a DR drill, have you found the run book to be out of sync with the current configuration? How many man-hours can be recovered through effective configuration management? Do you need a new release, version or patch level of the software? Is the service usage appropriate to capacity? Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role… In EVERY group, company, organization and department. Unless you are talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?' This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Software Change and Configuration Management investments work better. This Software Change and Configuration Management All-Inclusive Self-Assessment enables You to be that person. All the tools you need to an in-depth Software Change and Configuration Management Self-Assessment. Featuring 965 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Software Change and Configuration Management improvements can be made. In using the questions you will be better able to: - diagnose Software Change and Configuration Management projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices - implement evidence-based best practice strategies aligned with overall goals - integrate recent advances in Software Change and Configuration Management and process design strategies into practice according to best practice guidelines Using a Self-Assessment tool known as the Software Change and Configuration Management Scorecard, you will develop a clear picture of which Software Change and Configuration Management areas need attention. Your purchase includes access details to the Software Change and Configuration Management self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific Software Change and Configuration Management Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.
Privacy is one of the most urgent issues associated with information technology and digital media. This book claims that what people really care about when they complain and protest that privacy has been violated is not the act of sharing information itself—most people understand that this is crucial to social life —but the inappropriate, improper sharing of information. Arguing that privacy concerns should not be limited solely to concern about control over personal information, Helen Nissenbaum counters that information ought to be distributed and protected according to norms governing distinct social contexts—whether it be workplace, health care, schools, or among family and friends. She warns that basic distinctions between public and private, informing many current privacy policies, in fact obscure more than they clarify. In truth, contemporary information systems should alarm us only when they function without regard for social norms and values, and thereby weaken the fabric of social life.
This book highlights the latest advances on the implementation and adaptation of blockchain technologies in real-world scientific, biomedical, and data applications. It presents rapid advancements in life sciences research and development by applying the unique capabilities inherent in distributed ledger technologies. The book unveils the current uses of blockchain in drug discovery, drug and device tracking, real-world data collection, and increased patient engagement used to unlock opportunities to advance life sciences research. This paradigm shift is explored from the perspectives of pharmaceutical professionals, biotechnology start-ups, regulatory agencies, ethical review boards, and blockchain developers. This book enlightens readers about the opportunities to empower and enable data in life sciences.
Data is at the center of many challenges in system design today. Difficult issues need to be figured out, such as scalability, consistency, reliability, efficiency, and maintainability. In addition, we have an overwhelming variety of tools, including relational databases, NoSQL datastores, stream or batch processors, and message brokers. What are the right choices for your application? How do you make sense of all these buzzwords? In this practical and comprehensive guide, author Martin Kleppmann helps you navigate this diverse landscape by examining the pros and cons of various technologies for processing and storing data. Software keeps changing, but the fundamental principles remain the same. With this book, software engineers and architects will learn how to apply those ideas in practice, and how to make full use of data in modern applications. Peer under the hood of the systems you already use, and learn how to use and operate them more effectively Make informed decisions by identifying the strengths and weaknesses of different tools Navigate the trade-offs around consistency, scalability, fault tolerance, and complexity Understand the distributed systems research upon which modern databases are built Peek behind the scenes of major online services, and learn from their architectures