Computerized system

Up-to-day reliability requirements as applied to NPP strength maintenance govern development of new generation of computerized systems for in-service inspection. These systems in parallel with capabilities of ordinary ultrasonic techniques allow to reconstruct high resolution image of inner flaw and increase available amount of information. 

Another standardization matter relative to computerization of materials information is that of terminology (41) (see Nomenclature). Pull terminological standardization is not expected to be realized until the twenty-first century, but the hazards of lack of such standardization ate exacerbated in computerized systems. 

Maintenance "indicators" are available to help facility staff determine when routine maintenance is required. For example, air filters are often neglected (sometimes due to reasons such as difficult access) and fail to receive maintenance at proper intervals. Installation of an inexpensive manometer, an instrument used to monitor the pressure loss across a filter bank, can give an immediate indication of filter condition without having to open the unit to visually observe the actual filter. Computerized systems are available that can prompt staff to carry out maintenance activities at the proper intervals. Some of these programs can be connected to building equipment so that a signal is transmitted to staff if a piece of equipment malfunctions. Individual areas can be monitored for temperature, air movement, humidity, and carbon dioxide, and new sensors are constantly entering the market. 

The standard requires the supplier to have a computerized system for receipt of customer planning information and shipping schedules unless another method is agreed with the customer. 

The standard requires a computerized system for on-line transmittal of advanced shipment notification and a method of backup in the event of failure. 

The customer will advise on the format of the advanced shipment notification (ASN). A computerized system will give you flexibility such that you are able to transmit the information immediately the shipment is loaded. You could use a fax machine as your backup since transmission is nearly as fast but this is likely to present the customer with data-handling problems. A computerized transmission feeds the data directly onto the customer database, by-passing the manual data-entry stage. Your backup system should do the same in order that your customer perceives no noticeable change in the information. 

Arrange for backup systems in the event that the computerized system breaks down. 

The recommended initial step is to determine the duration of the study period for the analysis by first defining a start date. The end date is determined by the maintenance records. For computerized systems, the last update of the overall system provides the end date. For manual systems, it may be necessary to define an end date to accommodate the lag time in updating records. The start and end dates define the maximum calendar time that a piece of equipment is available for service. The operating time for this equipment will be equal to or less than the calendar period, depending on plant operations and the equipment s operating mode. 

Figure 4-311. Drill-off test curves generated by a computerized system. (Courtesy Anadrill.)...

One of the principal tasks facing the manager responsible for implementing a new plant layout is the planning and scheduling of the many activities involved in the project. Modem computerized systems have evolved into easy-to-use tools that avoid the need for a detailed technical knowledge of planning techniques. 

Continuous in-line measurements and control of the mass material balance in the process, with automatic feedback to the reactants dosing devices (performed either by computerized system or by traditional flow control loops). 

QA personnel who audit and monitor the GLP compliance of computerized systems should be familiar with and/or receive training on each system that is utilized in... 

Computerized systems should be included in facility inspections of field sites and analytical laboratories. Items discussed previously, such as computer maintenance records and personnel training records, can be reviewed more thoroughly during the facility inspection. 

Many quality programs and company standards require the validation of computerized systems. Systems that generate or manipulate data must be validated to fulfill various regulatory requirements. Failure to perform adequate validation may result in a lack of confidence in the data generated and regulatory noncompliance. 

Because the validation of computerized systems is time consuming, expensive and resource intensive, many organizations are challenged to identify and prioritize which systems will be validated. There are organizational and system specific risk factors to consider in the regulated environment. Each organization must establish its own risk assessment process. 

The following considerations must be addressed when validating computerized systems ... 

Regardless of the regulatory area, the overall expectation is that organizations have determined the risks associated with the computerized systems utilized in their regulatory environments and that they have documented evidence of their efforts to minimize those risks and meet regulatory requirements. 

When appropriate, require that operators be capable of performing mechanical repairs of their own instruments. This is the simplest way of teaching instrumental function and greatly improves operator self-confidence. With the highly-computerized systems of today, it is likely that supplemental assistance from the manufacturer will be necessary for instrumental maintenance. 

Guide to Inspection of Computerized Systems in Drug Processing, found at http //www.fda.gov/ora/inspect ref/igs/csd.html. 

Until recently, the pressures used in MW reactions in sealed Teflon containers have been restricted to 600-700 kPa (6-7 atm) for safety reasons. However CEM [21] have developed computerized systems with pressure and temperature control using vessels capable of withstanding pressures of 1500 kPa or more. Teflon bombs produced by Parr [22] can accommodate pressures up to 8 MPa (80 atm) and temperatures up to 250 °C. However it has been reported that repeated use of the vessels above 150 °C can lead to distortions which reduce the safe pressure level [7]. For safety reasons, the vessels used in these higher pressure reactions are equipped... 

Equipment must be suitable, maintained and, where appropriate, calibrated. Computer systems used to generate, store and retrieve data should be of appropriate design and capacity, validated and suitably located. If there are computerized systems used to control environmental factors, then these also require the same consideration. Issues relating to computerized systems are covered in Section 9.2.1.8. 

Computerized System Requirements and Electronic Records Increasingly, computerized systems and electronic records are part of a laboratory s operations. However, records may be held in both paper and electronic format and the quality assurance required depends to some extent on the format of the definitive document. Because of space requirements involved with paper records and ease of retrieval of electronic records, the latter are gaining in popularity. The same requirements that we have for paper records, e.g. change control, readability and archiving, will still apply to electronic records. For this to be achieved, new procedures may have to be developed. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

The security of data is essential for GLP studies, whatever the format of the documentation. The security of computerized systems in a laboratory environment is generally taken care of by the organization s security system. There may be extra precautions necessary if the equipment is located remotely . Security of access is normally achieved by use of person-identification and a password which changes on a regular basis. 

The Study Director needs to have an understanding of the extent to which the computerized system impacts on the study results. The Quality Assurance team will also check that there are procedures in place to meet the GLP requirements for all stages of development, use and maintenance of the systems used. They will require read-only access to the system. 

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