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.
Red Woman
Integration with Apple CarPlay has made long road trips so much more enjoyable. The captivating narrators make each story come alive in a unique way. I'm in awe of how this app has brought new dimensions to my reading experience. Automated artwork and metadata retrieval make my library look organized and professional.
Tweety Bun Bun
ListenBook's support for a variety of audio formats ensures that my audiobook collection is always accessible. The quick access to chapters and controls makes the app a joy to use. I'm always in control. The audio filters make a noticeable difference. ListenBook provides an excellent listening experience.
Mr. Spy
This app has reignited my passion for reading, and I'm forever grateful. ListenBook has reignited my love for storytelling and learning, one audio file at a time. ListenBook's controls for looping and shuffling playback have made studying and revisiting content a breeze. Quick access to chapters is a blessing. No more scrolling through endless content.
Jo Jo Spooky
Audiobooks have become a part of my self-care routine, thanks to this app. This app's dedication to providing high-quality narration has made all the difference. ListenBook's player features are incredibly helpful. Chapters and bookmarks make navigation easy. The app is perfect for road trips. It keeps me entertained for hours.
Lope Lope
The app's customization options allow me to tailor the listening experience to my liking. I've fallen in love with literature all over again, thanks to this incredible app. ListenBook's dedication to optimizing for iOS 16 ensures a seamless experience on the latest devices. Efficiency meets audiobooks β this app's functionality is a true standout. Noise reduction on ListenBook Pro is impressive. My recordings sound crystal clear.
Storm Master
ListenBook's dedication to optimizing for iOS 16 ensures a seamless experience on the latest devices. Finally, an app that caters to audiobook enthusiasts like me. The diverse format support and user-friendly design are a game-changer. π±π Bookmarks are a fantastic tool for keeping track of important moments. They're a game-changer. The app is so reliable. Iβve never had any issues with it.
Hidden Tree
The ability to listen to books while multitasking is a game-changer for me. ListenBook's user-friendly interface and intuitive controls make it a joy to navigate through my audiobooks.
Miss Lucky
ListenBook's basic audio filters allow me to fine-tune the audio playback to suit my preferences. This app has brought back the joy of reading, even when I'm on the move. I can't get enough of ListenBook's silky-smooth playback and intuitive design. It's my go-to app for both leisurely listening and study sessions. Beautiful design and intuitive interface. Very user-friendly.
Doz
With this app, audiobook listening has become an integral part of my daily routines β it's a game-changer. Sharing audiobooks via AirDrop is incredibly convenient. Great feature! Playback speed and volume controls are top-notch. Highly recommend. The app is very easy to use. ListenBook makes managing my audiobook library simple. The app is so reliable. Iβve never had any issues with it.
Nutmeg
Listening to audiobooks has become my ultimate way to unwind after a long day. πββοΈπ Combining exercise and exploration β audiobooks make my runs more exciting! πββοΈπ§ Effortless audiobook management β this app's usability is a winner. Looping playback has revolutionized my language learning journey. I'm making rapid progress.
CommandX
The audio filters in ListenBook allow me to customize my listening experience. Speed up or slow down playbackβit's all up to me! It was fine. The narrator did an adequate job but nothing about the performance particularly stood out to me. Got me through my commute though.
MuseMaster
I can't imagine a day without this app β it has made my audiobook journey seamless and fulfilling. ListenBook's dedication to providing an excellent audiobook experience is evident in its smooth and silky playback. Love how I can adjust playback speed and audio volume. ListenBook caters to all my needs.
Bourbon Mirage
Audiobooks on this app have turned my exercise sessions into moments of education. ListenBook's innovative features, from audio filters to statistics, make it a standout app. π Rekindling my love for stories β this app's accessibility has reignited my passion! ππ Supports artwork and metadata perfectly. My library looks great!
Greek Rifle
Adjusting the narrator's voice tone is a fun way to personalize the listening experience. The listening stats feature is awesome. I can track my audiobook habits effortlessly.
High Woo
π± Turning my phone into a portal of endless stories β this app is pure magic! πβ¨ πΌ Elevating my work-from-home routine with this app's delightful audiobook selection! π»π The audio filters make a noticeable difference. ListenBook provides an excellent listening experience.
Candy Butcher
ListenBook's integration of artwork and metadata adds a visually appealing touch to my library. This audiobook was neither good nor bad - simply average. The narrator's delivery was professional but uninspired, and the recording quality was clean though not exceptional. It provided satisfactory entertainment without standing out from similar titles.
Chip Queen
Thanks to ListenBook's extensive statistics, I can track my audiobook consumption and celebrate my progress. Supports artwork and metadata perfectly. My library looks great!
Overrun
The ListenBook app has transformed my device into a treasure trove of knowledge and entertainment. This app's ease of use has made my long drives educational and enjoyable. Adjusting playback speed has given me greater control over my audiobook experience. I can optimize my learning and enjoyment by customizing the pacing.
Charms
ListenBook's features are a dream come true for anyone who loves to learn on the go. π‘ Embracing audiobooks while tidying up the house β it's like having a helper! π π This app is a game-changer for audiobook enthusiasts. The interface is intuitive, and the playback is seamless! Excellent support for various audio formats. Very satisfied.
Lord Nikon
I can't imagine my life without this app β it's my constant source of books. Sharing audiobooks with friends through AirDrop is a creative way to share the love of literature. ListenBook has completely transformed how I enjoy audiobooks. The chapter navigation is seamless, and the statistics feature is a fun way to track my listening progress. The app is stable, fast, and incredibly user-friendly. Five stars!
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