Assuring Product Integrity PDF Download

Author: Eugene R. Carrubba
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 270

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Author: Eugene R. Carrubba
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 264

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Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Manufacturing, and Trade
Publisher:
ISBN:
Category : Children's paraphernalia
Languages : en
Pages : 336

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Author: Orlando López
Publisher: CRC Press
ISBN: 1000223035
Category : Business & Economics
Languages : en
Pages : 203

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Book Description
Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.

Author: Kim H. Pries
Publisher: CRC Press
ISBN: 1420072064
Category : Business & Economics
Languages : en
Pages : 386

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There are many books on project management and many on embedded systems, but few address the project management of embedded products from concept to production. Project Management of Complex and Embedded Systems: Ensuring Product Integrity and Program Quality uses proven Project Management methods and elements of IEEE embedded software develop

Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 826

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Author: The Open Group
Publisher: Van Haren
ISBN: 9401800936
Category : Education
Languages : en
Pages : 82

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This Management Guide provides guidance on why a technology provider should use the Open Trusted Technology Provider Standard (O-TTPS) – Mitigating the Risk of Tainted and Counterfeit Products (approved by ISO/IEC as ISO/IEC 20243:2015) and why they should consider certification to publicly register their conformance to the standard. The O-TTPS is the first standard with a certification program that specifies measurable conformance criteria for both product integrity and supply chain security practices. The standard defines a set of best practices that ICT providers should follow throughout the full life cycle of their products from design through disposal, including their supply chains, in order to mitigate the risk of tainted and counterfeit components. The introduction of tainted products into the supply chain poses significant risk to organizations because altered products can introduce the possibility of untracked malicious behavior. A compromised electronic component or piece of malware enabled software that lies dormant and undetected within an organization could cause tremendous damage if activated remotely. Counterfeit products can also cause significant damage to customers and providers resulting in rogue functionality, failed or inferior products, or revenue and brand equity loss. As a result, customers now need assurances they are buying from trusted technology providers who follow best practices with their own in-house secure development and engineering practices and also in securing their out-sourced components and their supply chains. This guide offers an approach to providing those assurances to customers. It includes the requirements from the standard and an overview of the certification process, with pointers to the relevant supporting documents, offering a practical introduction to executives, managers, and those involved directly in implementing the best practices defined in the standard.As the certification program is open to all constituents involved in a product’s life cycle this guide should be of interest to: • ICT provider companies (e.g. OEMs, hardware and software component suppliers, value-add distributors, and resellers),• Business managers, procurement managers, product managers and other individuals who want to better understand product integrity and supply chain security risks and how to protect against those risks and,• Government and commercial customers concerned about reducing the risk of damage to their business enterprises and critical infrastructures, which all depend heavily on secure ICT for their day-to-day operations.

Author: Kim B. Clark
Publisher:
ISBN: 9780000906038
Category : New products
Languages : en
Pages : 116

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Products with integrity perform superbly, provide good value, and satisfy customer's expectations in every respect, including such intangibles as their look and feel.

Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on District of Columbia
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 1450

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Author:
Publisher: DIANE Publishing
ISBN: 1428950494
Category :
Languages : en
Pages : 121

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