Software installation

State-of-the-art systems with flexible software allow for utility interface. These systems are all currently capable of data monitoring and of responding to realtime pricing, depending only on the software installed on the user-interface computer and the number of sensors the customer has installed for cnd-usc monitoring. 

IQ is defined as documented verification that all key aspects of the hardware and software installation adhere to appropriate... 

Verification of correct software installation (proper software versions loaded). 

Note As is often the case, the HPLC system will be under computer control, which is likely to be part of a data-handling system. Since the data generated from the OQ hardware tests typically require chromatographic data handling, the data-handling software should be validated beforehand. The data-handlingfLC control software installation and IQ/OQ implementation, which are not addressed in this chapter, may take a considerable amount of time. This is often the case since this process typically involves an initial client/server implementation. 

Another expensive factor of HCS is software. All HCS instruments have on board tools for image analysis and various level of sophistication for data analysis and viewing. Often image and data analysis is done after the acquisition of the screening plates in order not to slow down the microscope. Vendors therefore offer off-line licenses increasing the cost of software further. The image analysis software installed on instruments is often restricted in functionality to deliver easy-to-use software, although some vendors... 

If your menu says Oread rather than Oread CIS, you do not have the proper software installed and will need to reinstall the software. If your software says Oread CIS, then you have the proper version installed. If you need to reinstall the software, reinstall both the Oread Lite software as shown in Appendix A.l and the libraries for this text as shown in Appendix A.2. Do not forget to reinstall the libraries. When you install the Oread software, make sure you select Capture CIS as shown ... 

For some of the examples, you may wish to simulate a circuit provided with the software installation. The easiest way to use the example files is to open the files installed on the hard drive. However, in some cases, these files may not be available and you must use the files from the CD-ROM that accompany this text. To use these files you must take two steps (1) use the Windows Explorer to copy the files of interest to a directory on your hard drive, and (2) use the Windows Explorer to change the properties of those files to not read-only. 

Software validation is not separately defined in the quality system regulation. The FDA considers software validation to be the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled [14]. Software validations have special concerns on software installation, implementation, and utilization. A software validation consists in several tests, inspections, and verifications performed to assure the adequate installation and use of software and that the tasks performed meet all the specifications defined. Software validations must be performed under the environmental conditions to which software will be submitted. This is particularly important in medical devices that are used under special conditions, such as close to or inside the human body. 

Verify correct software installation (e.g., verify that all files are loaded). Utilities to do this should be included in the software itself. 

Make a list with a description of all software installed on the computer. 

Install application software and perform IQ (set up, define, and document configuration settings, verify proper software installation through installation verification routines). 

The installation should be documented. The accuracy of software installation should be verified, and for networked systems, drawings with diagrams should be generated. The instrument should be tested for compliance to user requirements and functional specifications, as defined during the design qualification. Critical parameters should be tested before and during routine analysis. System suitability... 

System access security Diagnostic checks Operator interfaces Software installation verification Software backup and restoration Control and monitoring loop operation Alarm, event, and message handling Safety and operational interlocks... 

System software installed as designed, and successful startup and... 

The software installation test cases may be developed with the collaboration of the application support personnel, the application expert, or a system user. 

If a validation plan is available, the software installation qualification should be addressed in this plan. If there is no validation plan, the software installation plan may be addressed in either a standalone document or as part of the installation qualification protocol. The software installation qualification plan identifies the activities to be completed and the responsible parties. 

The software installation qualification can be executed in parallel with, or after, the hardware installation qualification. 

Prior to software installation, a back-out or roll-back plan and procedure must be documented. If the planned installation fails, the back-out plan is implemented and the restoration activities and results are documented. The back-out plan includes information on performing a backup of the system, and/or making use of an existing backup of the system, which has been verified prior to software installation... 

If possible, a printout of the installation audit or system log file should be captured at the time of software installation and retained as documented evidence. In some cases, the supplier may provide internal diagnostic software that verifies the successful installation/connection of the computer technologies. A printout of any such diagnostic test results or reports should be retained as evidence. If it is not possible to capture this evidence, then the expected results of a successful installation must be indicated in the IQ protocol, and the actual observed results documented. 

Once the software installation qualification protocol has been completed, the test results, data, and documentation are formally evaluated. The written evaluation should be presented clearly and in a manner that can be readily understood. The structure of the report can parallel the structure of the associated protocol. The report should also address any nonconformances encountered during the software installation qualification and the resolution. The software installation qualification report summarizes the results of the verification and testing of all technologies that are part of the system. 

The Software Installation Qualification Report can either be a standalone document or may be incorporated into the system qualification summary report. 

The approved Software Installation Qualification Report should be submitted for retention by the appropriate records retention organization. 

OPERATING SYSTEM AND UTILITY SOFTWARE INSTALLATION VERIFICATION... 

The installation of system software and its associated components is verified according to normal software installation qualification practices. (Refer to Software Installation Qualification in this chapter.)... 

Standard software packages are called canned or COTS (Commercial Off-The-Shelf) configurable packages. The qualification of standard software packages is performed according to normal software installation and operational qualification practices. (Refer... 

Security configuration management (all listed implementation features must be present) The organization to implement the necessary measures, practices, and procedures for the security of information systems Documentation Hardware/software installation and maintenance review and the testing of the security features System inventory Security testing Virus checking... 

The graphical user interface is created during the software installation using a so-called wizard, which checks the configuration of the plant in cooperation with the user. The wizard permits the adaptation of the graphical user interface to the existing plant set-up and the activation of controller, I/O channels, limit switches, etc. 

Figure 2 Diagram of a generalized 2D-PIV setup showing all major components flow channel with the particle seeded fluid flow, laser sheet pulses illuminating one plane in the fluid, a CCD camera imaging the particles in the laser-illuminated sheet in the area of interest, a computer with PIV software installed, a timing circuit communicating with the camera and computer and generating pulses to control the double-pulsed laser. The PIV software setups and controls the major components, and analyses the images to derive a vector representation of flow field (see Plate 4 in Color Plate Section at the end of this book).

The installed software package also contains the AMDIS libraries onsite.cls and onsite.isl for calibration, test, and internal standard compounds (see Section 2.2). After software installation the hard disks are assigned to a particular GC/MS system. Since each instrument (defined by serial number) may be combined with any of the 5 electronic modules, 12 GC modules and 10 injector modules in possession of OPCW the actual instrument configuration needs to be defined. This is achieved by installing configuration files for the... 

Assembly should be eonducted using preapproved procedures. The quality of assembly work, including software installation, should be monitored. Many organizations deploy visual inspection and diagnostic testing to eonfirm that the computer system s hardware has been correctly assembled. Some companies tag assembled equipment that has passed such a quality check so that it can be easily identified. 

---