Hardware Design Specification developing

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. 

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 ... 

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. 

The SRECS shall be hardware designed and developed in accordance with the SRECS safety requirements specification (SRS). 

Software is not a physical entity and, unlike some hardware failures, software failures occur without advanced warning. One of the most common software failures is branching, that is, the ability to execute alternative series of commands based on differing inputs. The software branching capacity makes the commands extremely complex and difficult to validate once errors occur as an answer of a specific input, and until the introduction of that specific input error has not been detected. Software input can be almost any data and, and since it is impossible to introduce all data into a software, validation of data is extremely difficult. Thus, results are considered to be of high confidence level. The majority of software problems occur as a consequence of errors in the software design and development and are not directly related to the software manufacture. It is simple to manufacture several software copies that work perfectly and as the original one. 

Operating system code availability Software/hardware specifications Software/hardware design practices Product design records Program coding standards System development records System test records Programming tools Control of nonoperational software Removal of dead code ... 

During system development and build the supplier will normally be responsible for all software and hardware development tests and reports, with the pharmaceutical manufacturer involved as agreed upon under the contract. Development test specifications are to be used to demonstrate that the developed software and hardware provides the functionality and operation as defined in the system design specifications. 

Prepare design specification including any hardware configuration. Verify installation and performance of hardware components. Assess (audit) hardware development capability maturity of supplier. 

Custom (bespoke) hardware components All requirements for category 1, plus. .. Design specification required Subject to acceptance testing Supplier audit for hardware development Assembled systems from different sources require verification of compatibility Configuration defined in design documents... 

Although it dominated the market with its DOS operating system and its add-on Windows interface, Microsoft found that the constraints of DOS were rapidly making it difficult to take full advantage of rapidly improving hardware and software developments. The future of computing was clearly a 32-bit, preemptively multitasked system such as IBM s OS/2, but many current users had DOS-based software or older hardware that was specifically designed for DOS and would not operate outside of its Windows 3.1, cooperatively multitasked environment. 

In the initial models stage, product, test programs, software, and associated hardware are designed and developed. Completion is achieved when prototype hardware/software is fabricated and initial evaluation is started. This stage confirms that the initial model results match the initial product specifications. Finally, a ready-for-production checklist is reviewed by the product development team. One of the critical elements of this stage is the development and implementation of design and process platform characterization objectives and plans. 

Application software design and development Architecture To create a software architecture that fulfils the specified requirements for software safety To review and evaluate the requirements placed on the software by the hardware architecture of the SIS 12.4.3 SIS application software safety requirements specification SIS hardware architecture design manuals Description of the architecture design, for example, segregation of application S/W into related process subsystem and SIL(s), for example, recognition of common application S/W modules such as pump or valve sequences... 

As stated earlier, this standard addresses the same functions and utilities as discussed in connection with lEC 61508. The major difference is that, this is specifically meant for process industries in contrast to generalized nature of lEC 61508. Also it mainly addresses the end users and integrators, and not manufacturers. Differences between lEC 61508 lEC 61511 have been detailed out in Table VI/4.0-2. Other than those, there is a lot of commonality between the two, which is clearly depicted in Figs. 2 and 3 of the standard. Since ISA 84-00.01 and lEC 61511 are almost identical, such similarities have been shown in Fig. Vl/6.0-1 (mainly for ISA 84 applicable for lEC 61511, with necessary minor changes). For the process industry sector, for SIS standards, lEC 61508 should be referred to, whereas safety instrumented designers, integrators, and users need to refer lEC 61511. Similarly, in this sector for hardware, standards are developed as per lEC 61508-2 for proven hardware, lEC 61511 is to be followed. In... 

This promotes the basic requirements for design and development of E/E/PE systems including hardware and software architecture, sensor, actuators, and PE including embedded software, application specific integrated circuit (ASIC), etc. Major issues related to this shall include but not be limited to the following ... 

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