Hardware Design Specification

To allow the pharmaceutical manufacturer to understand the extent to which the system as defined meets the requirements of the URS To ensure a structured approach to the presentation of information that can be referenced to the URS and carried forward into the software and hardware design specifications... 

To define functional design requirements on which to base the detailed software and hardware design specifications To provide the base document for OQ testing... 

The hardware design specification must describe the hardware that will make up the computer system and the hardware interfaces. The defined hardware should be traceable back to statements in the FDS. Once the hardware design specification is produced and approved it is possible to generate a hardware test specification. 

The structure of the hardware design specification should be such as to facilitate comparison with the FDS. 

Software module test specification—for testing individual software components against the software module specification Hardware test specification—for testing the hardware components against the hardware design specification... 

The computer system URS and FDS, the subsequent software and hardware design specifications, and instrument data sheets are the reference documents for qualification protocol development. The basis and acceptance criteria for each test should be derived from the system parameters, data, and function requirements that have been specified. It is advantageous to commence development of the test procedures at the same time as the respective specifications— this to best ensure that requirements and tests correspond, are traceable, and can be better understood. 

Project Quality Plan Software Quality Assurance Program Functional Design Specification Hardware Design Specification Software Design Specification Software Module Design Specification Software Review Software Module Test Records Hardware Test Records Integration Test Records Instrument Spccs/Data Sheets Instrument Calibration Records Material Certificates... 

User Reqnirements Specification Functional Specification Hardware Design Specification Software Design Specification Software Controls Testing and Qnalification... 

The difference between a DCS, where the HMI is usually an integral part of the system, and a PLC, which usually contains a controller and an HMI, is that separate software and hardware design specifications exist, and there will be separate build and Module Testing. Additionally, Integration Tests must take place to ensure that the individual systems communicate and interact in the correct manner. Any assessment of the potential hazards of such a system, such as a Computer HAZard and OPerabiUty (CHAZOP) smdy, should cover the total system. 

The FS is developed into a hardware design specification (HDS) or a software design specification (SDS) or both. The SDS provides the facihty to break each functional requirement into appropriate subfunctions, increasing in detail at each subsequent level, until eventually the design reaches a state where it can be translated into software code. The SDS should mimic the sections of the FS but be specific to software constraction. Some examples are as follows ... 

Network Design Specification Hardware Design Specification - Software Design Specification - Wiring Specification - Eiectricai Specification... 

The circuit board components of some medical prototype devices may have to be reorganized in order to obtain a layout that will allow easy automatic assembly. Any changes must be noted in the Hardware Design Specification, and the new board must be checked against the prototype for functional equivalence. The FMEA report should be consulted to see if there are any critical components on the circuit board. If so, the manufacturer will have to make special arrangements to ensure that component traceabihty exists from supplier to circuit board to user. 

Installation Qualification (IQ) and QQ protocols will be developed to verify the installation and functional operation of the system. IQ verifies the software and hardware installation against the Software and Hardware Design Specifications, ensuring that the correct software and hardware components have been installed, identified, connected, configured and documented. OQ is functional testing of the application software and configuration focusing on GxP critical functionality. 

Are detailed Hardware Design Specifications (HDSs) produced ... 

Hardware Design Specification. The HDS will define the hardware platform to support the EAM architecture. It is likely that the pharmaceutical organization will impose corporate standards to ensure compatibility with other installations on the site. In many instances, the supplier will simply state... 

Technology-based AAC systems have taken two forms hardware designed specifically for this application and software that runs on mass market computer hardware. Three basic components comprise AAC systems. These are the language representation method (including acceleration techniques), the user interface, and the outputs. Generally, a multidisciplinary team evaluates the current and projected skills and needs of the individual, determines the most effective language representation method(s) and physical access technique (s), and then selects a system with characteristics that are a good match. 

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