Modifications, life cycle stages

Computer Systems Validation (CSV) The formal assessment and reporting of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance, and retirement, such that the user has a high level of confidence in the integrity of both the processes executed within the controlling computer system(s), and in those processes controlled by and/or linked to the computer system(s), within the prescribed operating environments) (MCA). 

Each product life cycle stage generates a different marketing and business climate that requires different approaches and strategies. The market development activity must recognize these differences and channel pertinent inputs into the overall marketing strategy plan so that modifications and revisions can be made as required. 

Assess Risk Management. For each life cycle stage, determine the actions needed to reduce and control risks from known and reasonably anticipated activities. These actions could include product modifications, engineering or management controls, protective equipment, or risk communication such as warning labels. The product developer might even decide to abandon the product. 

The integration of safety into the system life-cycle stages is shown in Figure 2.1. The choice of steps within the life cycle may be redefined as project requirements mature. Modification of the life cycle for specific customer or program needs is known as tailoring. ... 

As introduced in Section 14.2, bottlenecks in the process facilities can occur at many stages in a producing field life cycle. A process facility bottleneck is caused when any piece of equipment becomes overloaded and restricts throughput. In the early years of a development, production will often be restricted by the capacity of the processing facility to treat hydrocarbons. If the reservoir is performing better than expected it may pay to increase plant capacity. If, however, it is just a temporary production peak such a modification may not be worthwhile. 

Behavioral teratology is defined as a separate component of behavioral toxicology primarily in its focus on behavioral modifications resulting from toxic exposures during early development. In general, such studies track the outcome of such exposures over the postnatal and possibly into the juvenile and early adult stages of the life cycle. Outcome measures almost invariably include the development of physical... 

This standard provides detail of those activities related to setting and achieving specific safety-integrity targets and involves the design, installation, maintenance, and modification stages of the life cycle. Where the activity in question is already catered for elsewhere in the XYZ Ltd quality management system, this document will provide the appropriate cross-reference. 

The safety life cycle model is a useful tool in the development of safety related control systems. In concept it represents the interconnected stages from conception through specification, manufacture, installation, commissioning, operation, maintenance, modification and eventual de-commissioning of the plant. 

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