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.
Kitchen
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Voodoo Queen
Bookmarks are a fantastic organizational tool. They help me keep track of important moments in my audiobooks. This app is perfect for anyone who loves audiobooks. The interface is sleek and modern, and the playback controls are super responsive. I also appreciate the cloud integration, which lets me access my books from anywhere. Great work!
Baby Brown
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Jigsaw
I've discovered authors I'd never heard of before, and now they're among my favorites. Adjustable playback speed and volume control are top-notch.
Aqua Monsoon
This app's user-friendly design makes navigating through books a breeze. ListenBook's support for various download methods means I can acquire new content in a way that suits me best. I'm amazed at how effortlessly this app has made reading a constant in my life. ListenBook is a prime example of user-centered design. It's clear that the developers understand audiobook lovers' needs. CarPlay compatibility takes my driving experience to a whole new level. Audiobooks on the road have never been better.
McDreamy
Audiobooks have become my companion during long walks, transforming exercise into a pleasure. ListenBook's basic audio filters allow me to fine-tune the audio playback to suit my preferences. I love that ListenBook Pro allows me to customize the tone of the sound β it adds a personal touch. Finally, an app that caters to audiobook enthusiasts like me. The diverse format support and user-friendly design are a game-changer. π±π ListenBookβs playback speed control is very useful. I can listen at my own pace.
LerveDr
ListenBook's integration with AirDrop and sharing options makes it simple to spread the joy of storytelling. ListenBook's auto-rewind feature is a thoughtful addition that ensures I never miss a single word.
CodeExia
As a language learner, this app has been invaluable in improving my listening skills. Finally, an app that respects my busy lifestyle. Whether I'm commuting or exercising, this app's smooth playback and smart controls keep me engaged. πββοΈπ§ The audio filters make a noticeable difference. ListenBook provides an excellent listening experience. I love the chapter navigation feature. ListenBook makes it easy to jump between sections.
Despair
ListenBook's compatibility with different formats ensures I never have to worry about file conversions. Audiobooks have become my companions during daily chores, making them enjoyable. The automatic extraction of artwork and metadata adds a professional touch to my audiobook library.
Atlantic Rim
I can't imagine my audiobook routine without ListenBook's seamless audio player. I'm addicted to this app's ability to turn mundane moments into opportunities for intellectual growth. I'm in awe of this app's ability to make reading so accessible and convenient.
StorySculptor
ListenBook's customizable features, from playback speed to audio filters, cater to every audiobook lover's preferences. ListenBook's support for various download methods and audio formats ensures that I can always find what I'm looking for. This app has transformed my screen time into valuable learning and entertainment. As an audiobook enthusiast, this app is a dream come true. Its compatibility with various formats and easy navigation make it my ultimate reading companion. ππ§
Wiccan Thunder
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Wanted Candy
Kudos to the creators for making literature so accessible and enjoyable. ListenBookβs design is sleek and modern. The app is a pleasure to use.
Starshine
I've become so much more productive while cleaning or exercising β thanks to this app! Thanks to ListenBook's extensive statistics, I can track my audiobook consumption and celebrate my progress. User-centric audiobook joy β this app's ease of use is impressive.
ELLerG!c
The ability to switch between devices seamlessly is a game-changer for busy readers. ListenBook has become my trusted companion, making even the busiest days enjoyable. User-centric audiobook joy β this app's ease of use is a true marvel. Quick access to chapters and smooth playback. Excellent app! I love how ListenBook makes it easy to organize my audiobook library. The app supports all formats, and the import process is a breeze. The playback controls are responsive, and the sound quality is excellent. Highly recommend!
Spit Turanga
I'm impressed with the wide range of supported formats. Finally, an app that plays all my audiobooks flawlessly. Iβd listen to this narrator read anything! Their voice was so expressive and fitting for the material. The story itself was great, but the narration took it to the next level. Definitely a 5-star experience.
Kamikaze Granny
Being able to customize the listening duration is perfect for quick breaks. πΆ Swapping background music for the soothing voices of narrators β audiobooks have become my soundtrack for daily life. π΅π ListenBook's integration with CarPlay and Apple Watch is a seamless addition to my daily routine.
Vagabond Warrior
Finally, an app that turns my daily commute into an adventure through literature. I've recommended ListenBook to all my fellow bookworms. It's a true companion for audiobook lovers.
Homerun Diva
I can't get enough of this app β it's like having a personal storyteller in my pocket. ListenBook's support for playlists in the CUE format makes organizing and enjoying audiobook series a delightful experience. Automated artwork and metadata retrieval add a professional touch to my audiobook library.
Solitaire
The ability to adjust the playback speed has made my commute even more efficient. I'm in awe of how this app has brought new dimensions to my reading experience. Download options are abundant, from WiFi to iTunes. It's all about convenience with this app. The app is perfect for people who love to listen to books while commuting.
Playing a wide variety of audio formats
Works on all devices with iOS 13 and newer
Huge amount of features for a small price
Frequent updates to add new features and improve existing ones
Advanced playback controls
Live sound processing
Changing the timbre of the reader's voice and noise reduction
Translated into more than 20 languages
If you love listening to fiction audiobooks, ListenBook has features to make the process easier.
Edit book data: title, author, cover
Use equalizer to make the sound comfortable for you
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
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