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.

Never HIGHLIGHT a Book Again Includes all testable terms, concepts, persons, places, and events. Cram101 Just the FACTS101 studyguides gives all of the outlines, highlights, and quizzes for your textbook with optional online comprehensive practice tests. Only Cram101 is Textbook Specific. Accompanies: 9780872893795. This item is printed on demand.

Never HIGHLIGHT a Book Again! Virtually all of the testable terms, concepts, persons, places, and events from the textbook are included. Cram101 Just the FACTS101 studyguides give all of the outlines, highlights, notes, and quizzes for your textbook with optional online comprehensive practice tests. Only Cram101 is Textbook Specific. Accompanys: 9780470467084 .

The number of FDA regulations and the agency’s increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm’s employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions

Two of the most important developments of this new century are the emergence of cloud computing and big data. However, the uncertainties surrounding the failure of cloud service providers to clearly assert ownership rights over data and databases during cloud computing transactions and big data services have been perceived as imposing legal risks and transaction costs. This lack of clear ownership rights is also seen as slowing down the capacity of the Internet market to thrive. Click-through agreements drafted on a take-it-or-leave-it basis govern the current state of the art, and they do not allow much room for negotiation. The novel contribution of this book proffers a new contractual model advocating the extension of the negotiation capabilities of cloud customers, thus enabling an automated and machine-readable framework, orchestrated by a cloud broker. Cloud computing and big data are constantly evolving and transforming into new paradigms where cloud brokers are predicted to play a vital role as innovation intermediaries adding extra value to the entire life cycle. This evolution will alleviate the legal uncertainties in society by means of embedding legal requirements in the user interface and related computer systems or its code. This book situates the theories of law and economics and behavioral law and economics in the context of cloud computing and takes database rights and ownership rights of data as prime examples to represent the problem of collecting, outsourcing, and sharing data and databases on a global scale. It does this by highlighting the legal constraints concerning ownership rights of data and databases and proposes finding a solution outside the boundaries and limitations of the law. By allowing cloud brokers to establish themselves in the market as entities coordinating and actively engaging in the negotiation of service-level agreements (SLAs), individual customers as well as small and medium-sized enterprises could efficiently and effortlessly choose a cloud provider that best suits their needs. This approach, which the author calls “plan-like architectures,” endeavors to create a more trustworthy cloud computing environment and to yield radical new results for the development of the cloud computing and big data markets.

This book constitutes the thoroughly refereed post-proceedings of the 4th International Conference on Mathematical Knowledge Management. The 26 revised full papers presented were carefully selected during two rounds of reviewing and improvement from 38 submissions. The papers cover mathematical knowledge management. Topics range from foundations and the representational and document-structure aspects of mathematical knowledge, over process questions like authoring, migration, and consistency management by automated theorem proving to applications in e-learning and case studies.

This edited collection brings together a series of interdisciplinary contributions in the field of Information Technology Law. The topics addressed in this book cover a wide range of theoretical and practical legal issues that have been created by cutting-edge Internet technologies, primarily Big Data, the Internet of Things, and Cloud computing. Consideration is also given to more recent technological breakthroughs that are now used to assist, and — at times — substitute for, human work, such as automation, robots, sensors, and algorithms. The chapters presented in this edition address these issues from the perspective of different legal backgrounds. The first part of the book discusses some of the shortcomings that have prompted legislators to carry out reforms with regard to privacy, data protection, and data security. Notably, some of the complexities and salient points with regard to the new European General Data Protection Regulation (EU GDPR) and the new amendments to the Japan’s Personal Information Protection Act (PIPA) have been scrutinized. The second part looks at the vital role of Internet intermediaries (or brokers) for the proper functioning of the globalized electronic market and innovation technologies in general. The third part examines an electronic approach to evidence with an evaluation of how these technologies affect civil and criminal investigations. The authors also explore issues that have emerged in e-commerce, such as Bitcoin and its blockchain network effects. The book aims to explain, systemize and solve some of the lingering legal questions created by the disruptive technological change that characterizes the early twenty-first century.

There is a mountain of information on FDA regulation and compliance for medical device manufacturers. the task is daunting and very few busy manufacturers are regulatory mountain climbers. Reading the regulations provides only a small part of the picture. Understanding what the regulations mean and how compliance can be achieved in your environment is key. Graphic icons organize the text and provide a visual aid to definitions, regulations, procedures, documents, records, and points to remember. Applicable chapters also end with a FDA Investigator Icon, which summarizes what the FDA investigator will expect to see during an investigation.

In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Labora

They’re supposed to be useful tools, but whether they’re printouts, computer files, flowcharts, or forms, documents can often give more headaches than help. And yet without them, most organizations couldn’t function. ISO 9001 and other quality management systems place great emphasis on documents, and for good reason. Documents aren’t individual, stand-alone elements of the management process. They’re interrelated, formatted in different media, and controlled by various and distinct functions. Keeping critical information current and in the right hands requires more than just signing off on procedures. Document control is essential, but where should you begin? Inside you’ll find clear explanations about the document control process as well as practical solutions for creating, organizing, and maintaining documents, including: A discussion of different kinds of documents, including electronic media and QMS requirements Identifying and defining responsibility Understanding the relationship between documents and records Tips for document writers Managing and maintaining documents Issues of accessibility Handling revisions and deviations Writing document control procedures