Third-party software

Some of the major packages are better at visualization than others. In any case, there are a host of third-party providers with software on offer. Here then is what you might like to do with the results of the calculations above (and I used HyperChem to produce the following screen grabs). First of all an isosurface plot of the electron density (Figure 10.16). Next are isosurface densities for the highest... 

LIMS as rented service— The application service provision provider (ASP) is a means of obtaining access to software applications without the need to acquire expensive licenses and hardware or employ high-cost support resources [7]. The application is hosted on a third-party site with system maintenance, backup, and recovery provided by a third party. Products and services can be rented for a contract period on a fixed cost per user/per month basis. The advantages of obtaining LIMS in this fashion include reduced cost in initial investment and reduced requirement of resources for maintaining the LIMS. The continued security and integrity of the data transferred over the Internet is a major concern for this type of LIMS. 

In addition to the system controlling and data processing NMR software, a huge variety of third party software is available for any type of NMR imaging analysis and visualization. The following list is a selection of some of the commercially available software and software that is free, which can import NMR data in different formats. 

There are other ways to convert a single piece of SAS output to PDF. You can use a free script found on the Internet, such as ascii2pdf, or purchase a PDF file converter from a third-party software vendor. If you have Acrobat Distiller with Acrobat Version 5, you can use the PDF distiller macros in Microsoft Office to print a single file from Microsoft Word to PDF. 

By the nature of its interdisciplinary nature, functional genomics is almost invariably a collaborative effort at distinct locations. A practical approach to the data management of such projects that we follow is to localize all data in one server and allow all collaborators to access it remotely, conveniently through a web browser without having to install specialized software. This also allows access by third parties, after public release of the data sets. In fact, these massive data sets cannot be published in the traditional way. One leaves the data out of journal articles and merely indicates there how to access the data directly from this system. Functional genomics is changing even the sociology of science ... 

Some of your software may be in the form of a third-party or legacy component. It may be an infrastructure that you use to serve your middleware or may be part of the core of the system that implements part of the main business model. 

Based on technical report 32, PDA has established a third party inspection program in the field of software suppliers. It works like the one described for IPEC s BPE GMP audits. By March 2002, 117 auditors had been certified, and the audit repository center, as the service provider licensed by PDA, lists 22 audit reports [33]. 

The software further might allow basic data operations, e.g., to save the measured values for subsequent data processing with third-party programs, and the utilisation of other sensors such as thermocouples to control the temperature of the test sample. 

Another item of concern regarding Standard Software Packages is that the package by itself may not be Part 11 compliant. An example of this is a package that does not have Part 11-compliant audit trails functionality. In this case, the Standard Software package may need to be combined with third-party applications and/or plug-ins, in order to make it compliant with Part 11. 

The testing carried out in the development environment is not sufficient to verily the integrity and performance of the system. The application software must also be tested under actual conditions of intended use in the target or production environment. If the application is to be supplied by a third party in accordance with the end-user s requirements specification deliverable, it should be possible to carry out a completely prospective validation, as would be the case for a system developed in house, providing the requirement for validation is identified at the beginning. As with all systems, the responsibility for validation lies with the system s owner. 

Software program index (source code, executables, configuration files, data files, and third-party software such as operating system, library files, and drivers)... 

Are there records showing projects conforming to company practices What third-party hardware or software is used Are they supplied by reputable firms ... 

GxP regulations require that access to the software and relevant associated documentation should be preserved for a number of years after the system or software has been retired (see Chapter 4 and Chapter 11 for more details). Software licenses do not entitle pharmaceutical and healthcare companies to ownership of the software products they have purchased. All that has been purchased is a license, an official permission or legal right to use it for some period of time under defined conditions of use. Accordingly, some companies have established escrow (third party) accounts with suppliers to retain their access to software, but this is not mandatory. Access agreements directly... 

Loss of software support for aging versions of business critical systems can create significant business continuity and regulatory risks. Pharmaceutical and healthcare companies should provide a definitive statement on how they will maintain critical systems where support has historically been provided by third parties but that support is no longer available or set to expire. Measures need to be established to prevent adverse impact to product quality and product data and how they will ensure business continuity during any system outage. 

The determination of the sample size must be documented. An important aspect to consider in applying statistical sampling is the need to predefine the acceptability of similar systems. If the systems and their operational environment are exactly identical then a sample size of one may be sufficient. If the systems are not identical, then consideration needs to be given to what is an acceptable delta for the differences between those similar systems. Some of the deltas that one can consider may include the differences in software (operating systems, third-party tools, application program) version, patches, and fixes, as well as the deltas in hardware and equipment. 

User specific application software, written by the user or by a third party for a specific user to meet the specific functional needs in the user s laboratory. Examples are macros to customize a system for specific user needs. This software must be validated prior to and during routine use. 

If the standard software supplied by the vendor does not cover all of the user s requirements, user specific software is developed as an add-on macro, either by the user, the vendor, or by a third party. 

The next step is either to select an existing system for the analysis task or to pnrchase a new system. When a new system is purchased, it is often purchased not just for a specific analysis but also for use in general applications in the laboratory. In this case, the Reqnirements Specifications should include a representative mix of the anticipated applications, and the FSs shonld be set such that the instrument can handle all of the requirements. Next, the nser shonld look for an instrument on the market that best meets these requirements. If the selected system does not provide all of the fnnctions — for example, regarding software — the user can decide whether to develop these himself or ask the vendor or a third party to do so. 

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