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For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards.This book was written to assist quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting process validations that meet regulatory and certification requirements. It provides an introduction and background to the requirements necessary to perform process validations that will comply with regulatory and certification body requirements.
This is an important and timely book. Students of organizational behavior for the last 15 years have been asking how to integrate the technology of data gathering and data analysis with critical organizational challenges. This book shows how to do that, using the field of customer service to illustrate the broader point. This volume allows lay readers to understand telemetry and helps them enhance their data-gathering activities to strengthen customer relations.Author of The Agenda Mover: When Your Good Idea Is Not Enough and Transforming the Clunky Organization: Pragmatic Skills for Breaking Inertia (Cornell University Press)Telemetry is an automated way of collecting data at remote sites or locations, and transmitting it to collectors at receiving site for monitoring, analyzing, and driving improvement actions. This book provides the necessary knowledge and information to understand the telemetry infrastructure and associated details. It will enable readers to implement a telemetry program to address customer experience pain and improve customer experience.The authors of this book have all served in different roles and capacities in one of Silicon Valley's premier technology companies. These roles include software engineering, customer assurance, quality management, technology development, and implementation. Their paths intersected in the area of quality management, and they have witnessed first-hand how the latest technology/market transitions around Internet of Things (IoT), digitization, and telemetry are impacting the company they work, as well as the high-tech industry and global economy as a whole.The real-time nature of data and the advent of machine-learning algorithms have set the stage for a new era that the authors call adaptive customer experience. The premise of this concept is that real-time availability of customer experience data opens the door for real-time responses based on machine-learning algorithms. This creates an unprecedented opportunity to change the relationship between customers and the systems they depend on in their digital world. The proliferation of sensors and improvements in data science capabilities are creating an environment where the possibilities for telemetry are limitless. The book provides several examples of use cases and applications that help bring telemetry to life.
The rapid pace of technology often catches organizations unprepared and unable to take advantage of every leading-edge benefit. Cloud technology allows forward-thinking companies to launch products and services rapidly, control costs, streamline processes, and mitigate risks-when done correctly. This book addresses technological basics, as well as practical steps for implementing and fitting the cloud into your overall business strategy-which ultimately benefits your bottom line in delivering the best possible product and services to customers quickly.Capitalizing on their collective years of experience working in Silicon Valley, authors Jarvis, Anand, and Jose share best practices for adopting the cloud, including:¿ Calculating cloud usage and crafting a cost management strategy¿ Breaking down the total cost of ownership (TCO)¿ Optimizing DevOps practices for the cloud¿ Understanding the challenges and risks involved with cloud migration and securityArmed with step-by-step guidance, you can generate a plan of action to meet and exceed your cloud management goals.
Audience This book is intended for senior software engineers, software managers, and non software managers within software organizations whose aim is to create an engi neering environment within their company or organization.
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