Life cycle phases

Although acquired immunity to some parasitic diseases may lower the level of infection, absolute immunity as seen in bacterial and viral infections is seldom seen in parasitic diseases. Since parasitic infections produce a wide variety of antigens because of the many life cycle phases, it is more difficult to identify a constant antigenic protein against which specific antibodies are protective. However, malaria remains a likely candidate for a vaccine and there are ongoing studies to develop one. 

In the life cycle phases of product manufacturing, the focus of resource efficiency moves from the material applied per unit to resources used in the various production phases, for example, cooling lubricants, compressed air or hydraulic oil and on the energy requirements of the production processes [24]. Process relevant information is based on equipment energy consumption curves. Each curve is specific to a production equipment item and enables an accurate determination of the energy consumption of the item over the production time. 

Most survey respondents indicated that they perform reactive hazard evaluation studies during specific life-cycle phases of a process or product. These phases include process development, commercial process design, periodic re-evaluation, and before proposed modifications. The protocol for hazard evaluation of reactive systems varies from company-to-company. At a minimum, all surveyed companies employ qualitative hazard evaluations.58... 

Figure 7.1 Schematic of life cycle phases of a typical chemical process.

Fig. 1. Diagram of the major reproductive life cycle phases, commencing with sexual maturation and moving through fertilization, fetal development, parturition and postnatal development and ending with a sexually mature individual capable of starting the cycle over again.

The established methodology for computer system validation enables identification and control of each life-cycle phase and its associated document deliverables. It is also recognized that throughout the validation life cycle there is a level of dependency on the methods, services, and resources of the computer system supplier. 

The validation life-cycle phases align closely with the project stages for new computer system applications. With this in mind, it is recognized that a significant proportion of the documentation required for validation may be generated by a well-controlled and -documented project. 

The process for implementation and prospective validation of computer systems outlined in Figure 3 depicts the system application activities within each life-cycle phase and identifies key issues and considerations for each step. The process includes for evaluation of both the computer system product and the system supplier s working methods. The same life-cycle approach may be applied to validate the associated control and monitoring instrumentation [9]. 

Each qualification must be formally reported to ensure an approved and audit-able transition to subsequent life-cycle phases. Qualification summary reports for the system must be prepared by the pharmaceutical manufacturer and should be kept in the validation file. Each qualification report should confirm the qualification test acceptance and review associated change control records. The report must present a documented record that clearly states the basis for concluding that the qualification is acceptable, particularly if there are any minor conditions or actions outstanding. 

Satisfactory completion, review, and reporting of each qualification, including those associated with field instrumentation and regulating devices, will release the computer system for the subsequent life-cycle phase. 

This life-cycle phase will normally involve all parts of the computerized operation, not just the computer system. It is therefore essential that other equipment such as operating plant, utilities, and services that are part of or related to the manufacturing process have also been qualified or commissioned to the appropriate level prior to commencing PQ. 

Long period of exposure (days, weeks or months) relative to the life span of the test organism (i.e., > 10% of an organism s life span) and also relative to several life-cycle phases (e.g., development, reproduction) (Ferard et al., 1992). See also Chronic effects and Chronic toxicity. Volume 1(3,5), Volume 2(2,5,11). 

Activities may differ very much between Safety and Security depending on requirements. As an example, the Decommissioning and Disposal phase can be discussed briefly (Life Cycle Phase 16) ... 

The research approached travel motivation through a two-phased process - exploratory interviews and a major survey study. The interview phase of the study is reported in detail in Lee and Pearce (2002). Intensive interviews with a small number of travellers chosen because of their markedly different travel experience and life-cycle phases were conducted. The small sample consisted of Australian-based residents. 

Figure 3.7 presents a set of life-cycle phases that summarize the validation approach typically used within the pharmaceutical and healthcare industries. Life-cycle phases may be known by alternative names in different organizations. There is no standard glossary throughout the industry relating to naming conventions or groupings of phases. It is important, however, that all the activities covered by this chapter are included in any alternative scheme. 

The final staffing life-cycle phase is entitled maintenance and covers the prospective validation of new computer system systems and periodic revalidation of current computer systems. This phase is typically managed in-house, using work packages contracted to suppliers. At this stage, a set of... 

The second life-cycle phase addresses the capture of requirements and the selection of suppliers. It entails the following main activities, usually conducted sequentially User Requirements Specification (URS), GxP Assessment, Supplier Selection, and Supplier Audits. Getting this phase right is crucial to ultimate success. The issues that have to be managed can be summarized as follows ... 

Confirm completion of life cycle phase by phase... 

Life-Cycle Phase Systems Systems Systems Systems Capability Fix Error... 

Compnters are widely used in analytical laboratories for instrument control, data evaluation, and data management, and are subject to all validation and verification activities. Verification and validation activities to assess compnter systems used in analytical laboratories cover all life-cycle phases, from nser Reqnirements Specifications, design, development, and manufacturing to installation and operation. In this case stndy, users of computer systems will find guidelines on ... 

Testing and verification of life-cycle phases (reviews of Reqnirements Specifications, design, code inspections, test traceability matrix from test cases back to reqnirement specifications, are there release criteria for the phases )... 

Fig. 3 Testing and verification are done throughout all life cycle phases...

Since an assessment on the level of the material is not complete, an assessment on the level of products is required, which covers all life cycle phases, i.e. production, use and end-of-Ufe. Such a Life Cycle Sustainability Assessment (LCS) should be the core of an assessment, while it has to be completed by a variety of other tools, which address e.g. compliance with local emission limits and consumer protection regulations. Legal compliance requires other efforts than an overall sustainability assessment. Since compliance is an issue companies have to... 

Figure 12.3 shows the phases within a "cascade" approach and an "incremental" approach. Each box shows a different phase of the life cycle. The descending arrows show passage between one phase and the next (enabled only after the approval of "deliverables" related to the prior phase) the ascending arrows show system acceptance step by step (after the execution of the tests related to the specific phase). Note that the same life-cycle phases are still valid inside those different development methodologies. 

An overview of existing systems, including the life-cycle phase... 

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