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.
StarZen
I've never been this excited about my daily commute – thank you, audiobooks! I'm amazed by how this app effortlessly turns my daily routines into enjoyable learning sessions. Effortless audiobook management – this app's usability is a winner. The noise reduction feature in ListenBook Pro is a game-changer for enjoying clear recordings. I love the ability to share my progress with friends. It’s a fun feature.
Frenzy
Audiobook multitasking simplified – this app's functionality is a triumph. Beautiful layout and easy access to chapters. Really impressed with ListenBook. The app is perfect for people who love to listen to books while exercising. ListenBook is the best audiobook player I’ve ever used. The app is packed with features like customizable skip intervals, playback speed, and sleep timers. The interface is clean and easy to navigate, making it a joy to use. Five stars!
Miss Mustard
The variety of supported formats means I can enjoy audiobooks from different sources hassle-free. I’m so impressed with ListenBook. The app is reliable, fast, and packed with features like customizable themes and playback speed. The sleep timer is a lifesaver for bedtime listening. Highly recommend this app! Not the best audiobook I've heard but far from the worst. The production quality was good and there were no major issues with the narration.
Ember Master
With this app, reading is no longer a luxury – it's an essential part of my day. ListenBook's integration with AirDrop and sharing options makes it simple to spread the joy of storytelling. ListenBook's integration with CarPlay and Apple Watch adds a new level of convenience to my audiobook journey.
Vicious Street
Audiobooks have become my favorite workout companions, making exercise a breeze. I can't believe how easy it is to download and manage my audio content using ListenBook. ListenBook's sleek layout and quick chapter access have made my audiobook journey incredibly enjoyable.
Twin Blaze
With ListenBook, I can enjoy a wide range of audiobook formats without any hassle, making my listening experience seamless. Noise reduction and voice tone adjustment are excellent additions. This audiobook was an absolute pleasure to listen to! The narrator's voice was rich and expressive, perfectly capturing the tone of the material. I found myself completely immersed in the story, often sitting in my car longer than necessary just to hear what happened next. The production quality was excellent with clear audio throughout.
Admiral Tot
With this app, audiobook listening has become an integral part of my daily routines – it's pure bliss. I can't imagine my daily activities without this app – it's my go-to for staying informed and entertained. Effortlessly immersing in stories – this app's ease of use is a game-changer. ListenBook's commitment to a user-friendly interface and intuitive controls is evident in every aspect of the app.
DriftDetector
ListenBook's innovation, seamless playback, and versatile features make it a standout app. I can't believe how convenient this app has made my reading experience. Thanks to ListenBook, downloading audiobooks is a hassle-free process, regardless of the source. ListenBook Pro's noise reduction makes sure that background distractions don't interfere with my listening. Perfect for listening to educational content. Highly recommend!
Indestructible Potato
ListenBook has truly transformed my audiobook experience. The sleek interface, extensive format support, and easy downloading options make it my go-to app! I'm impressed by the app's performance – it's stable, fast, and tailored for audiobook enthusiasts.
EchoEnigma
Audiobooks have become my preferred way to unwind – and this app is my partner in crime. I love that ListenBook supports a wide range of formats, making my library diverse.
Black Fantastic
Navigating through my audiobook collection is a breeze – this app's intuitive interface and convenient controls have made my reading journey effortless. 📱📖 Kudos to the developers for making this app iOS 16 optimized. It runs like a dream! Looping playback helps me revise and memorize complex topics effectively. A study essential! Great app for listening to lectures and speeches. Highly useful!
Mr. Gadget
Audiobooks on this app have made my workouts more enjoyable and productive. I'm amazed at ListenBook's intuitive interface and precise controls – it's a joy to navigate. Finally, an app that lets me organize my audiobooks effortlessly. The library organization and book groups feature make navigation a breeze. Sharing audiobooks with friends through AirDrop is a fun way to introduce them to captivating stories.
Gingersnap Woman
My audiobook collection has never looked better. Thanks to automatic artwork and metadata. Supports all my playlists and bookmarks perfectly.
Shadow Chaser
⭐️ A round of applause for an app that prioritizes functionality – I can seamlessly switch between audiobooks and other tasks. 👏🎧 Not the best audiobook I've heard but far from the worst. The production quality was good and there were no major issues with the narration.
Troubled Pie
I can't thank the developers enough for constantly updating and improving the app. Finally, an app that supports all my audiobook formats! ListenBook is a game-changer.
Pixie
ListenBook's commitment to excellence shines through in its user-friendly interface and smooth playback. ListenBook's support for CarPlay and Apple Watch makes it an essential companion for my daily commutes and workouts. It's convenience at its finest! ListenBook's dedication to providing an exceptional listening experience shines through in every aspect of the app. ListenBook has revolutionized the way I consume content. It's like having a personal tutor in my ear.
Prof. Screw
This app's user-friendly design makes navigating through books a breeze. 💡 Balancing learning and living effortlessly – audiobooks on demand, thanks to this app! 🎧💫 Navigating audiobooks effortlessly – this app's functionality is commendable. The sound quality is excellent. It feels like I’m in the story. The app is perfect for road trips. It keeps me entertained for hours.
Trouble Mittens
The interface is clean and intuitive. I was up and running in seconds. ListenBook has broadened my horizons by introducing me to a diverse range of audiobooks. It's a gateway to endless knowledge, entertainment, and inspiration. ListenBook’s playback speed control is very useful. I can listen at my own pace. The sound quality is excellent. It feels like I’m in the story.
Mr. Fabulous
The range of self-help and personal development audiobooks is truly enriching. 🎉 This app has turned my errands into exciting quests – I can conquer the grocery store while enjoying a book! 🛒📖
Fire Feline
This app has made me appreciate the art of storytelling even more. Listening to books in their original language has improved my foreign language skills. ListenBook Pro's noise reduction feature is a blessing for clear listening in noisy environments.
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