Software documentation and

The sections below describe the most commonly used techniques. There are many variations and permutations for all of these. The reader is referred to the software documentation and original literature for clarification of the details. 

Document the methods you employ to denote inspection and test status for hardware, software, documents, and services. 

The following process is applicable for changes to any component of computer technology that performs functions on regulated products, including hardware, peripheral devices, system software and utilities, application software, documentation, and communications hardware and software. These components can be either purchased from an external supplier or developed in house by the company or its designee. 

This clause discusses the assumptions associated with the hardware and software used to develop the application software. Documentation and procedures are also discussed. 

In most commercial process simulators, model parameters for pure component properties and binary parameters can be found for a large number of compounds and binary systems. However, the simulator providers repeatedly warn in their software documentations and user manuals that these default parameters should be applied only after careful examination by the company s thermodynamic experts prior to process simulation. For verification of the model parameters again, a large factual data bank like the DDE is the ideal tool. The DDE allows checking all the parameters used for the description of the pure component properties as a function of temperature and of the binary parameters of a multicomponent system by access to the experimental data stored. On the basis of the results for the different pure component properties and phase equilibria, excess enthalpies, activity coefficients at infinite dilution, separation factors, and so on, the experienced chemical engineer can decide whether all the data and parameters are sufficiently reliable for process simulation. 

An SDL is a controlled collection of software, documentation, and associated tools and procedures used to facilitate the orderly development and subsequent support of software. The SDL includes the development configuration as part of its contents. 

Uncertain documentation practices (including both software documentation and coding practices developed on the fly in the early years of the computer industry) contribute to the magnitude and cost of the problem. In the... 

A modular scanner system for NDE has been developed. It consists of a selection of individual electronics and motor module components, supported by scanner configuration and control software. The modules are used as standard building blocks for construction of job specific, dedicated scanners as well and general purpose scanners. The use of modular scanner components significantly reduce the work, time and cost not only for the design and manufacture but also for establishing documentation and ensure compliance with the relevant EU-directive requirements. 

The software US-SCAN 3.0 (IBT GmbH, Ober-Ramstadt, Germany) provides all functions of a portable flaw detector and a powerful ultrasonic imaging in A-, B-, C- and D-scans. Not only motor driven scanners can he used, but also manual scanning systems with encoders. Further documentation and test reports can be carried out with Windows software. 

The great advantage of installing an ultrasonic system in a PC is that both the hardware (processor, grafics, power supply,. .) aud the software (evaluation and documentation) are directly available for the inspections. 

See if the software documentation suggests any other ways to change the DIIS method. You may have to run hundreds of calculations to become experienced enough with the method to know what works when and by how much to adjust it. 

The hardware and software used to implement LIMS systems must be vahdated. Computers and networks need to be examined for potential impact of component failure on LIMS data. Security concerns regarding control of access to LIMS information must be addressed. Software, operating systems, and database management systems used in the implementation of LIMS systems must be vahdated to protect against data cormption and loss. Mechanisms for fault-tolerant operation and LIMS data backup and restoration should be documented and tested. One approach to vahdation of LIMS hardware and software is to choose vendors whose products are precertified however, the ultimate responsibihty for vahdation remains with the user. Vahdating the LIMS system s operation involves a substantial amount of work, and an adequate vahdation infrastmcture is a prerequisite for the constmction of a dependable and flexible LIMS system. 

Electronic mail and electronic conferencing services are not counted as separate databases, but when such electronic services are included with a database they are counted as aspects of the associated database and the database is classified accordingly. Several commercial online services make software databases available online, eg, the Microsoft Programmers Library, MacTutor, and Atari RoundTable. Several producers offer CD-ROM databases containing software. Such software databases contain the coding and documentation for software packages and so are classified as software databases. These are different from directories of software that are classed as directory databases. 

Hardware, software, documentation, or information owned by the customer which is provided to a supplier for use in connection with a contract and which is returned to the customer either incorporated in the supplies or at the end of the contract. 

To ensure that QC and testing procedures are followed a quality control manual should be implemented. It is a document usually setup in a computer s software program that states and provides the details of the plant s quality objectives and how they will be implemented, documented, and followed. 

Does the computer room have limited access (e.g., are the servers physically/ logically secure) 2. Are there provisions for power backup 3. Is there a disaster recovery plan and is it periodically tested 4. Is there environmental monitoring 5. Are there off-site back-up facilities for key documents and software Is it readily retrievable ... 

FieldNotes user verification can be conducted by following the SOP written by Astrix, which can be downloaded from the Astrix Web site. The SOP contains a script that is typed into the computer system. If the printout matches the SOP script, then verification is complete. A record of this must be placed in the facility archive. This verification process takes 1 h or less. For FieldNotes, calculations are not verified at the field site since the manufacturer feels that the software developer and the sponsors have performed adequate validation of these calculations previously. This may, therefore, require a visit to the sponsor or to the manufacturer to confirm that this important step of the validation process has been completed and is adequately documented. By following the Astrix SOP, the user is simply ensuring that the program operates on their system(s). The SOP script must be typed in exactly as written in order to confirm the printout accuracy. QA must ensure that the verification documentation is properly archived. Just as with any other SOP, this SOP must be approved in writing by field site management to comply with GLP. 

Like software, documentation should be decoupled the dependency relationships between different parts should be clear, and there should be not very many of them. Documentation should make it easy to find out about one particular aspect of the design it should be clear what other things you must read. 

Asset development The design and creation of the reusable components that will be used in different contexts. This is carried out with more rigorous documentation and thought. Because software capital assets will be used in many designs, the impact of a change can be, for better or worse, quite large. 

Seek business rales in the current actual business process, the process as documented, and rales encoded in existing software systems (from user manuals, database triggers, and batch mainframe programs see Chapter 17, How to Reverse-Engineer Types). Restate these business rules in terms of the following (in descending order of preference) ... 

Category 3—Standard Software Packages These are commercial, off-the-shelf software packages. The package is not conhgured, and process parameters may be input into the application. The name and version should be documented and verihed during IQ. Compliance to URS should be tested during QQ. Supplier documentation should be assessed and used. 

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