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Compliance by Design
Author: Chong Ee
Publisher: IT Governance Publishing
Published: 2011-09-27
Total Pages: 230
ISBN-13: 184928296X
DOWNLOAD EBOOK →In Compliance by Design, Chong Ee will show you how your organisation can benefit from becoming compliant with the relevant national and international standards. You will discover how integrating controls into your processes will improve your security, increase your productivity, save you time and money, and increase your profits.
DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS
Author: Vernon Geckler
Publisher: Wasatch Consulting Resources LLC
Published: 2017-02-11
Total Pages: 441
ISBN-13: 0692835415
DOWNLOAD EBOOK →This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.
Standards for Internal Control in the Federal Government
Author: United States Government Accountability Office
Publisher: Lulu.com
Published: 2019-03-24
Total Pages: 88
ISBN-13: 0359541828
DOWNLOAD EBOOK →Policymakers and program managers are continually seeking ways to improve accountability in achieving an entity's mission. A key factor in improving accountability in achieving an entity's mission is to implement an effective internal control system. An effective internal control system helps an entity adapt to shifting environments, evolving demands, changing risks, and new priorities. As programs change and entities strive to improve operational processes and implement new technology, management continually evaluates its internal control system so that it is effective and updated when necessary. Section 3512 (c) and (d) of Title 31 of the United States Code (commonly known as the Federal Managers? Financial Integrity Act (FMFIA)) requires the Comptroller General to issue standards for internal control in the federal government.
Design Controls for the Medical Device Industry, Third Edition
Author: Marie B. Teixeira
Publisher: CRC Press
Published: 2019-08-02
Total Pages: 248
ISBN-13: 1351261479
DOWNLOAD EBOOK →This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements
IT Control Objectives for Sarbanes-Oxley
Author: IT Governance Institute
Publisher: ISACA
Published: 2006
Total Pages: 128
ISBN-13: 1933284765
DOWNLOAD EBOOK →Compliance Controls A Complete Guide - 2020 Edition
Author: Gerardus Blokdyk
Publisher: 5starcooks
Published: 2019-09-10
Total Pages: 304
ISBN-13: 9780655919070
DOWNLOAD EBOOK →How do you assess the compliance controls pitfalls that are inherent in implementing it? How can you become more high-tech but still be high touch? What are the essentials of internal compliance controls management? If you do not follow, then how to lead? What are the business goals compliance controls is aiming to achieve? Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role... In EVERY group, company, organization and department. Unless you are talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?' This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Compliance Controls investments work better. This Compliance Controls All-Inclusive Self-Assessment enables You to be that person. All the tools you need to an in-depth Compliance Controls Self-Assessment. Featuring 911 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Compliance Controls improvements can be made. In using the questions you will be better able to: - diagnose Compliance Controls projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices - implement evidence-based best practice strategies aligned with overall goals - integrate recent advances in Compliance Controls and process design strategies into practice according to best practice guidelines Using a Self-Assessment tool known as the Compliance Controls Scorecard, you will develop a clear picture of which Compliance Controls areas need attention. Your purchase includes access details to the Compliance Controls self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific Compliance Controls Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.
The PAYTECH Book
Author: Susanne Chishti
Publisher: John Wiley & Sons
Published: 2020-02-18
Total Pages: 261
ISBN-13: 1119551919
DOWNLOAD EBOOK →The only globally-crowdsourced book on the future of payments (“PayTech”), offering comprehensive understanding of a rapidly evolving industry at the centre of global commerce The movement of money between individuals, organisations and governments is crucial to the world economy. The payments industry has undergone immense transformation – new regulations, technologies and consumer demands have prompted significant changes to the tools, products and use cases in payments, as well as presented lucrative opportunities for entrepreneurs and FinTech professionals. As payment technologies become faster and more efficient, companies and investors are increasingly favouring PayTech innovation due to better customer experience, increased revenues and manageable risks. The PAYTECH Book brings together a diverse collection of industry experts to provide entrepreneurs, financial services professionals and investors with the answers they need to capitalise on the highly profitable PayTech market. Written by leaders in the global FinTech and payment sectors, this informative volume explains key industry developments and presents valuable first-hand insights from prominent industry practitioners. Contributors include advisors and consultants to the payments and financial services industry, entrepreneurs and business owners utilising cutting-edge PayTech capabilities, academic researchers exploring the social-political-economic impact of PayTech and many others. Detailed chapters cover essential topics such as cybersecurity, regulation and compliance, wholesale payments and how payment systems currently work and how PayTech can improve them. This book: Defines PayTech and identifies its key players Discusses how PayTech can transform developed markets and accelerate growth in emerging economies Describes how PayTech fits into the larger FinTech ecosystem Explores the future of PayTech and its potential as an agent of social change and financial inclusion Provides diverse perspectives on investment in PayTech and what consolidation and expansion will look like The PAYTECH Book: The Payment Technology Handbook for Investors, Entrepreneurs and FinTech Visionaries is an indispensable source of information for FinTech investors and entrepreneurs, managers from payments companies and financial services firms and executives responsible for payments in government, corporations, public sector organisations, retailers and users of payments.
Internal Control Audit and Compliance
Author: Lynford Graham
Publisher: John Wiley & Sons
Published: 2015-02-02
Total Pages: 420
ISBN-13: 1118996216
DOWNLOAD EBOOK →Ease the transition to the new COSO framework with practical strategy Internal Control Audit and Compliance provides complete guidance toward the latest framework established by the Committee of Sponsoring Organizations (COSO). With clear explanations and expert advice on implementation, this helpful guide shows auditors and accounting managers how to document and test internal controls over financial reporting with detailed sections covering each element of the framework. Each section highlights the latest changes and new points of emphasis, with explicit definitions of internal controls and how they should be assessed and tested. Coverage includes easing the transition from older guidelines, with step-by-step instructions for implementing the new changes. The new framework identifies seventeen new principles, each of which are explained in detail to help readers understand the new and emerging best practices for efficiency and effectiveness. The revised COSO framework includes financial and non-financial reporting, as well as both internal and external reporting objectives. It is essential for auditors and controllers to understand the new framework and how to document and test under the new guidance. This book clarifies complex codification and provides an effective strategy for a more rapid transition. Understand the new COSO internal controls framework Document and test internal controls to strengthen business processes Learn how requirements differ for public and non-public companies Incorporate improved risk management into the new framework The new framework is COSO's first complete revision since the release of the initial framework in 1992. Companies have become accustomed to the old guidelines, and the necessary procedures have become routine – making the transition to align with the new framework akin to steering an ocean liner. Internal Control Audit and Compliance helps ease that transition, with clear explanation and practical implementation guidance.
Government Auditing Standards - 2018 Revision
Author: United States Government Accountability Office
Publisher: Lulu.com
Published: 2019-03-24
Total Pages: 234
ISBN-13: 0359536395
DOWNLOAD EBOOK →Audits provide essential accountability and transparency over government programs. Given the current challenges facing governments and their programs, the oversight provided through auditing is more critical than ever. Government auditing provides the objective analysis and information needed to make the decisions necessary to help create a better future. The professional standards presented in this 2018 revision of Government Auditing Standards (known as the Yellow Book) provide a framework for performing high-quality audit work with competence, integrity, objectivity, and independence to provide accountability and to help improve government operations and services. These standards, commonly referred to as generally accepted government auditing standards (GAGAS), provide the foundation for government auditors to lead by example in the areas of independence, transparency, accountability, and quality through the audit process. This revision contains major changes from, and supersedes, the 2011 revision.
