Hardware platform

Good management requires the ability to stay current with technology. Eor this reason the EDS has been designed on a hardware platform (Eigure 4-99) that provides expansion capabilities for new hardware and software packages. The many available packages include ... 

The software system and hardware platform must be well known and mature before being considered to be Configurable Software otherwise the software validation activities for Custom-Built systems must be used. 

Perhaps the easiest choice to make in defining computer requirements is the hardware. Many people may disagree with this viewpoint. There are dozens of choices of popular hardware platforms, depending on the size of your business or your personal preference. The hardware is, however, not important. The software runs your business. Defining the software that will be needed to do a job is the hard part. Once the software has been chosen, the hardware requirements of the software define the hardware needed. 

Many of the aforementioned features are combined in integrated molecular modeling software such as SYBYL, Chem-X, COSMIC,80 Quanta and CHARMm, BIOGRAF, Insight and Discover, Chemlab, and MOLIDEA. These packages are available on a variety of hardware platforms ranging from personal computers (PCs) to mainframe computers. 

Hardware Platform Application Software Sonrce Code Review... 

The intended operating environment for the system (e.g., hardware platform, operating system, etc., if this is a design constraint)... 

Hardware platform, data load, interfaces to other systems... 

IQ should focus on the installation of the hardware platform, the loading of data, and the setting up the interfaces to other systems. This will include the following ... 

Suppliers usually make sure their products are backward compatible so that legacy systems can be seamlessly replaced by new systems. Suppliers typically develop their upgrades for use on the same hardware platform. Full compatibility, however, is more than this. The new product must... 

The FDA has in the past promoted the ability to reprocess electronic records, that is, to retrospectively process necessary raw data again using the same or equivalent conditions to prove the integrity of original records. Such processing requires metadata data about data. Audit trail information is insufficient to reprocess electronic records. Details of the software originally used to create and maintain the records are also required to reprocess records together with hardware platform dependencies. 

In the case of outsourcing the support for the hardware platforms and network that run the chromatography data system software to the internal IT Department, a Service Level Agreement (SLA) has to be written. This SLA should cover procedures such as ... 

System retirement occurs at the end of the life cycle of any computerized system. However, there are little or no directly stated regulatory requirements for formal system retirement or general advice on how to undertake the task. System retirement is typically considered when a CDS including file formats, operating systems, and hardware platforms becomes obsolete. 

Hardware Platform Details with Unique Identification (e.g.. Serial Numbers)... 

Labeling of Hardware Platform Equipment (Including Interface Cabinets)... 

The software development facilities must approximate the final installation configuration. This is to ensure software developed during the project is capable of execution on the hardware platform used for the IPC installed on site. 

The FIDS will define the hardware platform to support the EMS 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 the hardware requirements and allow the pharmaceutical manufacturer to procure the hardware, especially when the EMS architecture is comprised of a number of systems from a variety of suppliers. Table 31.9 provides the typical contents of the HDS. The Installation Qualification (IQ) shall be developed to verify the major critical components stated in the HDS. 

Database applications can be installed on stand-alone PCs, host computers, or may have client server architecture. The hardware platform supporting the application requires qualification. Hardware testing (Installation Qualification) should include ... 

Installation Qualification (IQ) is a phased process for these systems. Prior to OQ the hardware platform must be qualified against the specified design. This is no differenf from sfandard IQ and checks on fhe following may be included ... 

Set-up of the various system environments must be managed. Documentation must be developed to describe the hardware platform and installed software, including any network infrastructure. Hardware architecture design documentation should be prepared. A diagram should be included to illustrate the geographic distribution of any client-server hardware. Client-server software also needs to be defined. Clients are often referred to as either thick or thin, depending on whether they require substantial or minimal application-related software. Client-server software can be considered to consist of ... 

An Installation Qualification (IQ) is needed to define and execute tests to verify successful installation of the hardware platform and resident software. As the project ramps up, the system is likely to require expansion to cope with a larger user base in which case the IQ must be revised. The IQ usually includes ... 

Inventory and configuration checks for the hardware platform (clients, server, and network)... 

Environmental checks made in computer room housing hardware platform on power supplies, backup power supplies, temperature, and humidity... 

Hardware Platform GAMP (2001) All computer hardware deployed to run software application programs. The definition covers servers, CPUs, memory devices, and peripheral controllers. [Adapted.]... 

Peripherals GAMP (2001) Hardware deployed to extend the capability of the hardware platform. It includes printers, modems, keyboards, tape drives, screens, and scanners. 

There can be little doubt that the pioneering work of dementi and coworkers provided much impetus for subsequent developments, many of which were based on implementing the replicated data methods, initially developed on the LCAP systems, onto more affordable microprocessor-based hardware platforms typified by the Transputer and i860 RISC chip. 

VIBRATE (normal modes), VOID (protein packing), and mdXvu (visualization of AMBER trajectory files). QCPE has also accepted the responsibility to distribute semicommercial academic software, such as MM2, MM3, MOPAC 93, POLYRATE, PEFF, and COMPARE-CONFORMER. Most programs in library are in FORTRAN and are available as source code. Current catalogs and information are available by anonymous ftp from qcpe6.chem.indiana.edu (129.79.74.206). Many of the programs run on several hardware platforms, including DEC VAX, IBM, Silicon Graphics, Stardent, Sun, Fujitsu, and Cray. 

In the introduction to this section, we remarked that Whereas a printed page can be copied with little regard to the nature of the material, usually paper, on to which it is copied, the correct execution of computer software is usually highly dependent on the hardware upon which it is implemented. The performance of the software packages described in the previous section is usually strongly dependent on the hardware platform on which it is implemented and this in turn determines the range of application that can be considered. 

Typically, quantum chemistry packages are suppied for a range of hardware platforms. For example, gaussian 03 is available for machines from a a range of vendors with different cpu and operating systems ... 

In distributing any quantum chemistry packages, each machine specific implementation has been tailored to the given hardware platform taking account of the computer architecture. In brief, computer architecture comprises at least three main subcategories ... 

To cope with the bewildering variety of software approaches and hardware platforms it is beneficial to make use of models for these different aspects. Thus, we need to detail programming models, parallel computer models and performance models. Designing these types of models are large subjects in themselves [12,22,23]. For the case of MD we need to select the models that fit our needs best and put them to work. 

Until the late 80 s, the software development was very much curtailed by the limitations of hardware, where the size of the memory was the most critical factor. Today, about a decade later, the most critical aspect for large scale parallel MD simulation is not the hardware, but the software. Coping with increased problem and algorithmic complexity, as well as, varying hardware platforms is a daunting task. Adding the requirement of optimal use of hardware resources makes the development or modification of an efficient and portable parallel MD simulation software a formidable challenge. 

Part 11 defines records management as the creation, signing, modification, storage, access, and retrieval of records and the software and hardware platforms used in these processes. This regulation applies to any documentation required by an FDA predicate rule. The Authorities cited for the rule are Secs. 201-903 of the Federal Food, Drug, and Cosmetic Act (21U.S.C. 321-393) Sec. 351 of the Public Health Service Act (42 U.S.C. 262)]. For example, 21 CRF 820.70 requires documentation of process and production controls in quality systems for medical devices. This is a predicate rule. If any of this documentation is created, signed, modified, stored, accessed, or retrieved electronically, the requirements of... 

HOS stands for Basic Input/Output System. The BIOS communicates between the computer and devices. The BIOS is usually stored in ROM. It was created by IBM to act as a translator to run the same operating systems on different hardware platforms. When the operating system needs to access a piece of hardware, it would now ask the BIOS, rather than just taking control of the hardware. The use of BIOS prevented programs from fighting over hardware. As long as the operating system (such as DOS) uses the BIOS for its hardware requests, it can run on different hardware platforms. The BIOS creates a standard reference point for many different types of hardware. 

Computational science is concerned with the effective exploitation of computer hardware in modelling and simulating a wide variety of processes. Computational science is therefore concerned with the development of computer software based on appropriate theoretical models. This software is then executed on a given hardware platform thereby providing information about the studied systems and new insights into their behaviour. 

The cost of developing and maintaining high quality software which can effectively exploit a given hardware platform often exceeds the cost of the hardware itself. Documentation is a key element of high quality software... 

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