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" Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. "
ESL Design and Verification: A Prescription for Electronic System Level ... - 296. lappuse
autors: Grant Martin, Brian Bailey, Andrew Piziali - 2010 - 488 lapas
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Code of Federal Regulations: Containing a Codification of Documents of ...

2001
...requirement with which a product, process. service, or other activity must conform. (z) Validation means confirmation by examination and provision of objective...particular requirements for a specific intended use can be consistently fulfilled. (1) Process validation means establishing by objective evidence that...
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The Code of Federal Regulations of the United States of America

2006
...requirement with which a product, process, service, or other activity must conform. (z) Validation means confirmation by examination and provision of objective...particular requirements for a specific intended use can be consistently fulfilled. (1) Process validation means establishing by objective evidence that...
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Principles and Practices of Method Validation

Aleš Fajgelj, Árpád Ambrus - 2000 - 305 lapas
...clear expectations. The International Organization for Standardization (ISO) defines validation as "confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled".1 For analytical methods, this includes the establishment of...
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Dictionary of Computer Science, Engineering and Technology

Philip A. Laplante - 2000 - 560 lapas
...the lack of specifics and clarity and which is allied to imprecision and fuzziness. validation (1) confirmation by examination and provision of objective...requirements for a specific intended use are fulfilled. In design and development, validation concerns the process of examining a product to determine conformity...
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Applications of Reference Materials in Analytical Chemistry

Peter Roper, Vicki Barwick, Shaun Burke, Ron Walker, Richard Lawn, Peter Bedson - 2001 - 147 lapas
...Assessing Measurement Uncertainty 6.1 What Is Method Validation? The ISO definition of validation1 is 'confirmation by examination and provision of objective evidence that the particular requirements for a specified end-use are fulfilled'. There are alternative definitions of validation, from other sources,...
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Design Controls for the Medical Device Industry

Marie Teixeira, Richard Bradley - 2002 - 254 lapas
...product already in distribution based on accumulated production, testing, and control data. Validation: confirmation by examination and provision of objective...specific intended use are fulfilled. Verification: confirmation by examination and provision of objective evidence that specified requirements have been...
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Reliability Verification, Testing, and Analysis in Engineering Design

Gary Wasserman - 2002 - 416 lapas
...Welfare: Food and Drug Administration, Part 820 — Quality System Regulation (ASQ, 1998): 1. Validation: confirmation by examination and provision of objective...particular requirements for a specific intended use can be consistently fulfilled. 2. Verification: confirmation by examination and provision of objective...
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Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack)

Interpharm - 2003 - 64 lapas
...requirement with which a product, process, service, or other activity must conform. (z) Validation means confirmation by examination and provision of objective...particular requirements for a specific intended use can be consistently fulfilled. (1) Process validation means establishing by objective evidence that...
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Best Practices in Software Measurement: How to Use Metrics to Improve ...

Christof Ebert, Reiner Dumke, Manfred Bundschuh, Andreas Schmietendorf - 2005 - 295 lapas
...individual or organization that uses the operational system to perform a specific function. Validation. Confirmation by examination and provision of objective...specific intended use are fulfilled. Verification. Confirmation by examination and provision of objective evidence that specified requirements have been...
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Forensic Science: An Illustrated Dictionary

John C. Brenner - 2003 - 296 lapas
...quantitation. linearity. precision. range. ruggedness. selectivity and specificity. and trueness. Validation Confirmation by examination and provision of objective...requirements for a specific intended use are fulfilled. Value The expression of a quantity in terms of a number and an appropriate unit of measurement. van...
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