User’s design specification

IQ provides documented evidence that the system is assembled, installed, plumbed, and wired according to the user s design specifications, vendor recommendations, and appropriate codes and standards. Vendors t5rpicaUy provide much of the hardware documentation. 

Items to be Included in a User s Design Specification (UDS) for ASME Vill-2 Vessels... 

The ASME Code, VIII-2, requires a formal design report with the assumptions in the User s Design Specification incorporated in the stress analysis calculations. These calculations are prepared and certified by a registered professional engineer experienced in pressure vessel design. As with the User s Design Specification, the Manufacturer s Design Report is mandatory and the certification reported on the Manufacturer s Data Report. This is kept on file by the manufacturer for live years. 

Specific electronic states may also be specified using the Gue s=Alter keyword, which allows you to explicitly designate orbital occupancies. See the Gaussian User s Reference for details. 

WASP/TOXIWASP/WASTOX. The Water Quality Analysis Simulation Program (WASP, 3)is a generalized finite-difference code designed to accept user-specified kinetic models as subroutines. It can be applied to one, two, and three-dimensional descriptions of water bodies, and process models can be structured to include linear and non-linear kinetics. Two versions of WASP designed specifically for synthetic organic chemicals exist at this time. TOXIWASP (54) was developed at the Athens Environmental Research Laboratory of U.S. E.P.A. WASTOX (55) was developed at HydroQual, with participation from the group responsible for WASP. Both codes include process models for hydrolysis, biolysis, oxidations, volatilization, and photolysis. Both treat sorption/desorption as local equilibria. These codes allow the user to specify either constant or time-variable transport and reaction processes. 

Standardized aboveground enclosures are available in a wide variety of materials, sizes, and configurations. Many options and security features are also available for each type of enclosure, and this allows system operators the flexibility to customize an enclosure for a specific application and/or price range. In addition, most manufacturers can custom-design enclosures if standard, off-the-shelf enclosures do not meet a user s needs. 

Design qualification (DQ) is the process used to determine a system that will function within the intended purpose. It can be compared to a user s requirements document for a piece of software. For example, if a CE is being purchased to run DNA sequencing samples, then the system purchased will need to include a fluorescence detector. The main vendors for CEs have similar options for their CE instruments reducing the utility of DQ protocols. Their main utility is to define the specific equipment needed for the purchase order. This only needs to be performed before the system is purchased initially. If desired, this can also be done when additional features need to be purchased (i.e., new detectors, etc.). 

If one s purpose is to determine only the presence or absence in a data base of a specific structure, this can be accomplished with the search option IDENT , as is shown in Figure 11. This program hash-encodes the query structure connection table and searches through a file of hash-encoded connection table for an exact match. The search, which is very fast by substructure search standards, has been designed specifically for those users who, to comply with the Toxic Substances Control Act [26l have to determine the presence or absence of specific compounds in Environmental Protection Agency files. 

A new device that is specifically made in accordance with a duly qualified medical practitioner s written prescription and which gives, under the practitioner s responsibility, specific design characteristics, and is intended for the sole use of a particular patient is permitted to be marketed without CE marking imder provisions referring to custom-made devices. The prescription may be made by any person authorised by virtue of their professional qualifications to do so. Mass produced devices that need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices. 

The Business Layer is in the center of CRS where the core business functions reside. Any business application has a workflow—the steps it takes to accomplish one or many tasks or transactions. Clearly analyzing and understanding the workflow is essential to designing the Business Layer correctly. Use case specifications capture workflow from a user s perspective. The System Activity Diagram is an excellent tool to capture system workflow from a system perspective. Figure 12.1 is the System Activity Diagram (CAD) of CRS. 

Validation in quality systems includes establishment of procedures on how to qualify the equipment and machinery, how to verify the design of products, how to verify the process designed, how to verify the achievement of production procedures, how to validate the process developed, and how to validate the methods for measurement and assay. Validation also requires verification of specifications or acceptance criteria of in-process parameters relating to both raw materials and intermediate (in-process product) and finished products, and verification of acceptance criteria for in-process parameters relating to operating conditions of machinery and equipment. Further, when the medical device is assembled at the user s site, validation includes establishing procedures of how to verify assembly. 

Inspection A manual testing technique in which program documents [specifications (requirements, design), source code or user s manuals] are examined in a very formal and disciplined manner to discover any errors, violations of standards or other... 

Design Qualification (DQ) is the first validation element of a new facility system or equipment, where adherence to the user s specifications and to GMP rules is demonstrated. Installation Qualification (IQ) follows with the verification of adequacy of the area, installation of equipment pipelines, utilities, instrumentation, and conformity of the material used to the project specifications. At the Operational Qualification (OQ) phase, carried out after installation of all equipment, it is verified whether the system, when in operation, complies with the acceptance criteria defined in the validation plan. Once the OQ phase is successfully finalized it is possible to proceed with the calibration procedures, operation and cleaning, operator training, and preventive maintenance program. After IQ and OQ are concluded, it is time for the Performance Qualification (PQ), with the aim of verifying that what was designed, built, and operated results in a product that meets the expected specifications. Production and QC personnel are specially trained for these assessments. The tests can be done with the product of interest or a placebo, and are related to all operations, from raw material reception to product release (EC, 2001). 

Design qualification should always be performed by the user, whereas installation qualification for large, complex, and high-cost instruments should be performed by the vendor. In some cases, warranty is lost if the user installs the system. Operation qualification can be performed by either the user or the vendor. The decision mainly depends on the available resources at the user s site, and on the vendor s capability to offer such a service with high quality. Performance qualification should always be performed by the user because it is very application-specific and the vendor may not be familiar with the method. As PQ should be performed on a daily basis, this practically limits this task to the user anyway. On completion of equipment qualification, detailed documentation should be available, considering qualification checklist, procedures for testing, qualification test reports with signatures and dates, PQ test procedures, and representative results. 

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