Design, validation

Another way to examine scaleup of hydrodynamics is to build a cold or hot scale model of the commercial design. Validated scaling criteria have been developed and are particularly effec tive for group B and D materials [Gheksmau, Hyre and Woloshuu, Powder Tech., 177-199 (1993)]. 

The standard creates a distinction between design verification and design validation. There are two types of verification those verification activities performed during design and on the component parts to verify conformance to specification and those verification activities performed on the completed design to verify performance but more on this later. 

As part of the verification plan, you should include an activity plan that lists all the planned activities in the sequence they are to be conducted and use this plan to record completion and conformance progressively. The activity plan should make provision for planned and actual dates for each activity and for recording comments such as recovery plans when the program does not proceed exactly as planned. It is also good practice to conduct test reviews before and after each series of tests so that corrective measures can be taken before continuing with abortive tests (see also under Design validation). ... 

Within the clause on verification in ISO/TS 16949 there are no constraints on the standards to be applied to development models used for verifying the design. There are, however, requirements for prototypes under Design validation but they only apply when required by the customer. 

The standard requires that design validation be performed to ensure that product conforms to defined user needs and/or requirements. 

Design validation may take the form of qualification tests which stress the product up to and beyond design limits - beta tests where products are supplied to several typical users on trial in order to gather operational performance data, performance trials, and reliability and maintainability trials where products are put on test for prolonged periods to simulate usage conditions. 

Design verification measures (clause 4.4.7) Design validation records (clause 4.4.8.2)... 

Pre-launch A phase in the development of a product between design validation... 

Design Validation Testing of the device under intended use conditions, field trials, clinical trials... 

Design verification and design validation are both activities related to investigations of the performance of the developed device. However, there are important features that distinguish them from each other ... 

Design validation, on the other hand, is focussed on assessing if the device in its totality meets the user s needs and intended uses and functions correctly under the intended use conditions. Thus, evaluation will usually be carried out at field sites/(i-sites (hospitals) or, at a minimum, under simulated use conditions. In the case of high-risk devices this will normally involve actual clinical studies. Validation should be performed using initial production lots of the device or their equivalents. 

A schematic representation of the relationship between design verification and design validation and their interaction with other design activities is shown in Figure 9.13. 

Typical questions that need to be answered are whether the CQP-based system is well designed (validity), whether activities (procedures, instructions, completion of registration forms) related to the monitoring system are executed properly (verification), and whether conditions (checking temperatures, concentrations, and other quality attributes) of processes are really achieved (production process verification). 

Calibration design 22-sampIe mixture design Validation design leave-one-out cross-validation Preprocessing single-point baseline correction at 1100 nm Variable range 550 measurement variables 1100-2198 nra... 

Key Words Pharmacogenomics biomarker genomics DNA microarray clinical trial design validation... 

To produce an adequate validation close cooperation between key personnel and those involved with the computer systems is essential. People in responsible positions should have the appropriate training for the management and use of systems within their field of responsibility which utilizes computers. This should include ensuring that appropriate expertise is available to provide advice on aspects of design, validation, installation, and operation of computerized systems [12]. 

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