Audiobook Data Integrity: The Science, The Regulations, The Use by Richard Siconolfi in the ListenBook app
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Book description
Throughout history, humans have recognized the importance of collecting reliable data. The Quality Assurance field is no exception, as promoting regulated life science that supports human, veterinary, and environmental health remains at the epicenter of our work.But what defines data integrity, how does it differ from data quality, and how does it vary between regulations? What are the data integrity requirements specific to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Pharmacovigilance Practice (GVP), and other areas in regulated life science? What are specific, practical approaches to assessing data integrity?After deep discussion surrounding these questions, leaders from the Society of Quality Assurance (SQA) saw the need to examine data quality and data integrity within the specific context of the QA profession. They collected their findings, takeaways from many discussions, and months of research to create a practical handbook tailored for the QA discipline - a book written by Quality Assurance professionals, for Quality Assurance professionals.A key factor within Quality Assurance is that there are distinct differences in company data integrity policies and training, in what defines data quality and data integrity, organizational unit responsibilities, data integrity challenges and information needs, and in the use of electronic systems vs. paper-based systems to collect scientific data. Regardless of whether your system is electronic, paper-based, or hybrid, and regardless of the specific regulatory mandates of your area, this book will be your go-to reference on data integrity principles and regulations, data governance, specific auditing tips, and much more that you can apply not only within your organization, but also throughout your Quality Assurance career.Table of ContentsChapter 1. What Is Data Integrity and Data Quality?Chapter 2: Where Is It Written?Chapter 3. Data Integrity PrinciplesChapter 4. Roles, Responsibilities, and StakeholdersChapter 5. Data Governance, Classification, and RiskChapter 6. Data Collection, Metadata, and Audit TrailsChapter 7. Data Integrity Challenges - Questions to ConsiderChapter 8. What Does Data Integrity Look Like?Chapter 9. Training for Data Integrity AwarenessChapter 10. Audit Strategies for Assessing Data IntegrityChapter 11. The Future of Data IntegrityAppendix A. Regulations and GuidelinesGlossaryList of Figures and TablesIndexAbout SQASQA is an association of over 2,500 professionals who are dedicated to implementing Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), and Good Pharmacovigilance Practice (GVP) across industry, government, academia, and consulting. Learn more at SQA.org.
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Listening to fiction
If you love listening to fiction audiobooks, ListenBook has features to make the process easier.
Edit book data: title, author, cover
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Adjust the playback speed
Enjoy dark and light app themes
Supported formats: MP3, M4B, AWB, FLAC, OGG audio files and many more (must be DRM free)
Auto-Bookmarks make it easy to find your place
AirPlay support allows redirection of audio output.
VoiceOver support
Dark mode for night owls
Listening to audio lectures
Convenient bookmarking system helps you mark the most important places.
Unlimited bookmarks for each audiobook
Put your own cover on the wager
Share your audiobook with friends
Lock-screen control
Customise app with extensive options
Sleep timer with shake to reset, set custom notification sounds, and a few unique options
Auto rewind depending on paused time, customize rewind times to your liking
Removing background noise from recordings made in classrooms and meetings
Changing the timbre of the reader's voice for a better listening experience
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