Forms Management System

The user interface is designed using a menu technique the implementation today is in DEC S Forms Management System (FMS). It consists of a sequence of menus which allows the user to select different input and query functions. A function is selected by hitting only one key. Pre-selections on each level are available as well as a header line, providing information on the position of the current screen in the menu hierarchy. Another feature to facilitate usage of the system is the help facility for menu screens, where some fields have to be entered to specify query parameters, help is available for each field. 

The UK government enquiry into the Piper Alpha disaster in the North Sea in 1988 has had a significant impact on working practices and equipment and has helped to improve offshore safety around the world. One result has been the development of a Safety Management System (SMS) which is a method of integrating work practices, and is a form of quality management system. Major oil companies have each developed their own specific SMS, to suit local environments and modes of operation, but the SMS typically addresses the following areas (recommended by the Cullen Enquiry into the Piper Alpha disaster) ... 

A laboratory information management system (LIMS) is a computer or computer network used to automate the acquisition and management of raw analytical data. In its simplest form, it tracks samples and test results through analytical laboratories and provides summaries of the status of these samples and tests. In its most advanced form, the system is interfaced to the laboratory s instmmentation and communication network to allow automation of data gathering, compilation, and reporting. 

Given the breadth of activities that management systems address, there will almost certainly be variations in how they are applied. For example, the system your company s human resources department uses to recruit and hire new employees will probably differ in form and structure from Central Engineerings system for safety design. However, by analyzing some representative management systems you can arrive at some broad common traits. 

Having agreed on PSM goals and objectives, your next step is to conduct a more detailed assessment of the present status of PSM activities within your company, to form the basis for your implementation plan. This baseline assessment works against both the model you have selected for PSM and the characteristics that describe a sound management system, such as those described by CCPS. 

What Is the Expected Output or Work Product. The specific form of the finished product will vaiy according to your company s practices and needs. However, it s reasonable to expect that the team s efforts will ultimately produce a set of documented Standard Operating Procedures (SOPs) for the management system, or their equivalent within your organization (see Section 6.3). Interim work products may include progress reports (see Chapter 8), documentation of discussions and analyses, flowcharts, or other materials. 

Energy-management systems will form an important part of a multi-boiler installation, whether on steam or hot water. Boiler(s) for base load will be selected and further boilers brought on- or taken off-line as required. The important feature of these systems is that the selection of boilers coming either on- or off-line will be ahead of the load and programed to anticipate rising or falling demands. 

Pure paper-based data collection systems are most suitable for small and short-term studies. Their advantages are that no computer hardware or software is needed at the participating sites because data are recorded manually on paper forms that are transferred to the centralized location in batches. A major drawback is that participating sites do not have real-time access to their data because no database is created locally. However, both hardware and software are needed at the centralized location for the data management system. The type of hardware and software used is determined by the configuration of the centralized computer. The most commonly used platforms include Open VMS, Unix, or PC, and one of the most widely used software packages is SAS [16]. 

Validation of the data management system is typically done in two rounds. First, correctly completed data forms are entered to ensure that the system is not flagging any good data. In the second round, completed data forms with intentional data errors are entered. All errors must be identified by the system. 

Electronic-based data collection and management systems rely heavily on computer hardware and software at both the participating sites and the coordinating centers. The hallmark of the electronic-based data collection and management systems is the elimination of paper data collection forms. Instead of recording data on paper forms, data collectors enter data directly into a computer system where an electronic data record is generated for each form. The method of data transfer to the central location depends on the type of the electronic-based data collection and management system. 

The use of electronic-based data collection and management systems allows the easy tracking of patient progress in the trial. Patient, visit, and form status are tracked. Patient status can be in screening, excluded, randomized, withdrew, or completed study. Similarly, status codes can be assigned to protocol scheduled visits to indicate whether the visit occurs or not. Form status depends on the type of the data collection system. For example a form in a distributed data collection system can be incomplete, filled, completed, altered, or transmitted. ... 

The explosion of graphical software and the ability of database management systems to store graphical data provide a mechanism for designing and implementing clip art to convey certain meaning to the user. For example traffic lights have been used to convey the status of data collection forms. 

Thompson GS, Quan K, DuChene A. Case report form image management system for large multicenter clinical trials. Controlled Clin Trials 2001 P34. 

In the end, because of the importance of the data, it is imperative that the entire adverse event form data are cleaned. Reconciling the adverse event data with other clinical data in the clinical data management system can be very difficult if the data management system does not provide variable keys for linking such data. Adverse event data fall into the safety area of statistical analyses and are considered an event from a CDISC perspective. 

The randomization of a patient in a given therapy is the cornerstone of a randomized clinical trial. You may find these data in more than one place. They are often found within some form of Interactive Voice Response System (IVRS), but they may also be found in an electronic file containing the treatment assignments or on the CRF itself. If randomization data are found on the CRF, they usually consist only of the date of randomization for treatment-blinded trials. IVRS data are often found outside the confines of the clinical data management system and usually consist of the following three types of data tables. 

CH4 emitted from manure depends primarily on (i) the management system such as solid disposal system, liquid disposal systems, e.g., ponds, lagoons, and tanks, which can emit up to 80% of manure-based CH4 emissions, while solid manure emits little or no CH4. (ii) Environmental conditions are also important. The higher the temperature and moisture, the more CH4 produced, (iii) CH4 emissions also depend on the quantity of the manure produced, which depends on the number of animals housed, the amount of feed the consumed, and the digestibility of the feed, (iv) Manure characteristics depend on the animal type, feed quality, and rumen microbes present in the rumen and digestive tracks. Manure handled in liquid form tends to release more amount of CH4 when compared to solid or manures thrown into the pasture, which do not decompose anaerobically. High temperatures with neutral pH and high moisture content enhance CH4 production [45],... 

The management system has to contain procedures for dealing with complaints. This will generate yet another form of record. The complaint has to be recorded and the action(s) taken to resolve it. There will be corrective actions and preventive measures put in place as a result of the complaint. 

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... 

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