Testing management system

Written by Bruce Osterby (University of Wisconsin LaCrosse) the Test Bank is formatted for easy integration into the following course management systems PageOut WebCT and Blackboard... 

The Test Bank and Online Learning Center with self assessments quizzes and review aids are available m the various course management systems Please ask your sales representative for details if you are interested... 

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. 

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. 

Because many of the techniques, especially those associated with the recovery of materials and energy and the processing of solid hazardous wastes, are in a state of flux with respect to application and design criteria, the objective here is only to introduce them to the reader. If these techniques are to be considered in the development of waste-management systems, current engineering design and performance data must be obtained from consultants, operating records, field tests, equipment manufacturers, and available literature. 

Employee Participation Preparation for startup is an excellent opportunity to document employee participation. If a toller is covered under the OSHA PSM regulation, they must record PHA participants, procedure writers and reviewers, PSSR team members and test run team members. All these roles reflect the true intent of this element of process safety. Eveiyone benefits from intimate involvement in the management system used to protect life and health. 

As with previous, similar exercises, encourage your team to be creative. Like any sound management system, your PSM system probably creates unexpected side benefits over and above those related spedfically to safety performance. For example, the pilot test may have demonstrated that a new system, once installed, enabled the facility to reduce unplanned downtime with better planning and use of preventive maintenance. Or perhaps the pilot test process itself may have helped improve relations between the facility and corporate staff. 

Manager Ex will ensure that appropriate resources are made available for the design, installation, and testing of an integrated PSM and ESH management system. 

You will need to undertake a series of interviews to understand existing PSM and ESH programs. You may also need to conduct some interviews to confirm aspects of your quality management system. However, if the Quality Management system is not well documented this may indicate a weakness, and you should reconsider the wisdom of moving forward with the proposed integration. It is essential to test how the processes are actually functioning, as this frequently differs from any description, formal or informal. 

The Osprey River facility is about to undergo a revolution Osprey River has been selected for a pilot study to integrate all aspects of EHS into a single management system. This is the first stage of what will be a company-wide project. The pilot project will b e used to test the design and installation strategies and to firm up the costs and benefits of the overall project. 

It is clear that water quality management of the Great Lakes has resulted in a number of successes. However, major problems remain or will arise continually to test the management system and its capability. Some of these issues are summarized briefly below. 

Develop policy-supporting SOPs on computer systems. These may include development, testing, maintenance and support, quality assurance, change control, source code management, system retirement, retrospective evaluation, evaluation of vendor-supplied systems, etc. 

Laboratory data may consist of many different collections of tests, such as ECG laboratory tests, microbiologic laboratory tests, and other therapeutic-indication-specific clinical lab tests. However, laboratory data traditionally consist of results from urinalysis, hematology, and blood chemistry tests. Traditional laboratory data can come from what are called local laboratories, which are labs at the clinical site, or from central laboratories where the clinical sites send their samples for analysis. Often when the laboratory data come from a central laboratory, there is no physical CRF page for the data and they are loaded into the clinical data management system directly from an electronic file. Local laboratory data may be represented with a CRF page such as this ... 

Although the providers of proficiency testing schemes should have a quality management system in place, on occasions problems can arise which will affect the quality of the data evaluation being carried out. These can include transcription errors during data entry, mistakes in the report, software problems and inappropriate criteria for evaluation being used. Such problems should be remedied by the provider once the problem has been identified. 

You are employed in an analytical laboratory in a group measuring the concentration of residues of pesticides. Your company is developing tests for a new pesticide to determine the amount that is left in food after harvesting. You are asked to set up a quality management system, because your laboratory s management has decided that the quality of your group s analytical work should be assessed by an appropriate independent authority. 

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... 

Quality Audit is the only option available to them. It is therefore vital that, to ensure standards of quality are maintained, a laboratory must operate its own internal audits to test its quality management system. If the internal system of audits is not operating adequately, external assessment visits are liable to be traumatic experiences, awaited with trepidation and producing unexpected and embarrassing nonconformities in several areas of operation. 

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