 | 2001 - 756 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... | |
 | International Validation Forum - 1996 - 860 lapas
...Manual, Chapter 17, September 1994. Validity A state or quality of software that provides conformation that the particular requirements for a specific intended use are fulfilled. In design and development, validity concerns the process of examining a product or result to determine conformance to user needs.... | |
 | Aleš Fajgelj, Árpád Ambrus - 2000 - 328 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... | |
 | Peter Roper - 2001 - 168 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,... | |
 | Marie Teixeira, Richard Bradley - 2002 - 258 lapas
...product already in distribution based on accumulated production, testing, and control data. Validation: confirmation by examination and provision of objective...requirements for a specific intended use are fulfilled. Verification: confirmation by examination and provision of objective evidence that specified requirements... | |
 | Interpharm - 2003 - 68 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... | |
 | Gary Wasserman - 2002 - 418 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... | |
 | Christof Ebert - 2005 - 320 lapas
...individual or organization that uses the operational system to perform a specific function. Validation. Confirmation by examination and provision of objective...requirements for a specific intended use are fulfilled. Verification. Confirmation by examination and provision of objective evidence that specified requirements... | |
 | John C. Brenner - 2003 - 299 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... | |
 | Leonard Steinborn - 2004 - 452 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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Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. 
