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 β 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 β 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.
Gingersnap Woman
ListenBook has turned my downtime into an opportunity for exploration and growth. The ability to adjust the tone of the narrator's voice is a creative touch that adds depth to my listening. The statistics tracking is a nice touch. ListenBook helps me keep track of my audiobook habits. The audio quality is superb. ListenBook enhances my audiobook experience.
EchoEmissary
Finally, a way to enjoy literature on the go without straining my eyes. This app's convenience has turned my daily chores into moments of literary escape. Controls are intuitive and user-friendly, making my audiobook experience seamless. Love how I can adjust playback speed and audio volume. ListenBook caters to all my needs.
Cinder Coffee
πΆββοΈπ Embracing audiobooks as my companions during leisurely walks β nature and narratives, a perfect match! πΆββοΈπ§ Navigating audiobooks with ease β this app's design is user-centric. Finally, an audiobook player that supports all formats! No more converting files.
Light Lion
Who needs traditional books when you have this app? It's a game-changer. ListenBook's features make it the ultimate audio companion for any audiobook enthusiast. ListenBook has made me fall in love with audiobooks all over again β it's a must-have app. ποΈπ§ Soaking up the sun while indulging in beach reads β this app is my ultimate relaxation companion. ποΈπ
Sneaky Lady
The app's stability is impressive β it runs smoothly without any glitches. With this app, I can devour books like never before β it's incredibly efficient. Flawless support for various audio formats. Highly satisfied. The perfect balance between dramatic reading and natural storytelling. Felt like a friend telling me an amazing story rather than someone just reading words.
Vicious Street
This app has become my go-to companion, making my daily routine more exciting and insightful. Kudos to ListenBook for the intuitive design and easy-to-use controls. It's evident that they've put a lot of thought into user experience.
Miss Mustard
ListenBook's support for a variety of download methods means I can access my content in the way that suits me best. Looping playback has made memorization so much easier. I'm acing my exams! Looping playback helps me retain knowledge from audiobooks effectively. It's an invaluable tool. Looping playback helps me immerse myself in the content. It's my secret study weapon. ListenBookβs CarPlay support makes listening in the car a seamless experience.
Unleashed
I'm amazed by the app's versatility in downloading audio. It accommodates various sources seamlessly. The adjustable playback speed is a secret weapon for getting through educational content faster. My workouts have become more enjoyable and productive with ListenBook's compatibility with Apple Watch. Downloading over WiFi is super efficient. Saves a lot of time.
Nacho
With this app, I've discovered a new way to make my workouts and downtime more engaging and insightful. I love the ability to change the playback pitch. Itβs a unique feature.
Shadow Chaser
Adjustable playback speed is a fantastic feature. It allows me to customize my listening experience. The app is so easy to set up. I was listening to my books in no time. 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!
CyberScribe
This app has brought stories to life in a way that traditional reading never could. Drag and drop downloads directly from my web browser? That's a level of convenience I appreciate. ListenBook has transformed my daily routine into an opportunity to learn, relax, and enjoy. Perfect for listening to educational content. Highly recommend! Iβm 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!
Blink
This audiobook app is an absolute lifesaver! It brings my favorite stories to life with unparalleled convenience. π This app is a game-changer β its intuitive design and seamless functionality make listening to audiobooks a joy. ππ§ The app's seamless integration with Apple Watch makes it my perfect workout companion.
Racy Lady
I can't imagine my daily routine without ListenBook's intuitive layout and easy-to-access controls. I'm hooked on this app's effortless downloading process β I can have my favorite audiobooks in seconds. This app has made my daily walks a time for both exercise and learning. π©βπ³ Cooking up a storm while enjoying thrilling stories β this app adds flavor to my meals! π³π§
Sexy
This app's seamless integration with CarPlay and other devices has revolutionized my audiobook experience. π‘ This app's convenience is a blessing β I can squeeze in reading time between managing household tasks! π±π©βπ³ Looping playback is an invaluable study tool. It helps me absorb complex information effortlessly.
Rummy Stickers
This app is a blessing for those with busy schedules β it's like time travel through stories. Thanks to ListenBook's binaural audio processing, my extended listening sessions are fatigue-free. As an audiobook aficionado, this app is a dream come true. Its support for various formats and effortless navigation make it my perfect reading companion. ππ§ Sharing audiobooks with friends through AirDrop is a fun and interactive way to connect. This app is a must-have for anyone who loves audiobooks. The interface is intuitive, and the app supports all formats. I love the auto-bookmark featureβit saves my place automatically, so I never lose track. Highly recommend!
Demolition Queen
π My audiobook haven β this app is like a door to endless adventures and knowledge! ππ Seamless audiobook integration β this app's design is a true delight. ListenBook is my go-to companion for immersive audiobook experiences. The ease of use and extensive format support make it a must-have! I'm impressed with the wide range of supported formats. Finally, an app that plays all my audiobooks flawlessly.
Spooky Electric
ListenBook is a prime example of user-centered design. It's clear that the developers understand audiobook lovers' needs. ListenBook makes organizing my audiobooks simple. The app is very user-friendly.
Friday Ferrari
I've been recommending this app to all my friends β it's a true game-changer. I've become addicted to this app β in the best possible way! I'm addicted to this app's ability to turn mundane moments into opportunities for intellectual growth. Sharing audiobooks with friends through AirDrop is a wonderful way to spread the love of literature.
Scare Stone
ListenBook's support for various formats means I can explore a wide range of content without limitations. I'm amazed at how this app has turned my errands into exciting reading sessions. The app's interface is so sleek and modern. It's a joy to use. Supports all my playlists and bookmarks seamlessly. Very convenient.
Delicious Wing
I'm grateful for this app β it's made reading a part of my everyday life. The book groups feature is a thoughtful addition. It helps me keep my series and related titles together. Tone adjustment adds a unique touch to my listening experience. I'm hooked! ListenBook is hands down the best audiobook player Iβve ever used. The interface is clean, intuitive, and packed with features like customizable playback speed and sleep timers. It supports all formats, which is a huge plus for me. Highly recommend!
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