Project life cycle

Proof of noiLTmmont Factory commissionin Lifecycle Concept J Lifecycle /irnplementation Turnover /Management. 

Project management Project manager Project management Capital management Sponsor(s) and stakeholder communications 

Analytical matrix team Process analytical Process instrumentation selection and specification 

Process engineering Process engineer In-line/On-line analyzer integration Process understanding (IPOs, P and IDs, etc.) Facilitate risk assessments Process understanding Process Instrument integration 

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Review quality plans at each stage of the product/project life cycle for continued suitability. 

Labuschagne, C., and Brent, A., 2004. Sustainable project life cycle management The need to integrate life cycles in the manufacturing sector, International Journal of Project Management, 23 (2), 159-168. 

Company). The product of the FEL process is a design-basis package of customized information used to support the production of detailed engineering design documents. Completion of the FEL design-basis package typically coincides with project AFE (Authorization for Expenditure) or project authorization. Project authorization is that point in the project life cycle where the owner organization commits the majority of the project s capital investment and contracts. 

FIG. 9-23 Project life cycle cost-influence curve. 

The vendor supplied an unspecified case study that compared the costs of an existing pump-and-treat system with a pump-and-treat system that had been retrofitted to accommodate an FE ACTIVE. The projected life-cycle cost (adjusted for an inflation rate of 4% and a rate of interest of 5%) of the existing pump-and-treat system was calculated to be 3,930,000 (1996 dollars). The life-cycle cost (adjusted for a 4% inflation rate and a 5% interest rate) of the FE ACTIVE retrofit system was calculated at 945,000 (1996 dollars). Both estimates included capital costs, operation and maintenance expenses, and the cost of groundwater monitoring. Similarly, had the FE ACTIVE system been installed initially, its life-cycle cost would be 1,630,000 (1996 doUars). 

The cost and complexity of validation is often underestimated and can cause delays in bringing the product to market. Validation requirements for a project should be identified as early as possible in the project life cycle to ensure that adequate time and cost is allowed to complete them successfully. It is particularly important to establish the documentation required from suppliers and contractors working on the project, and the extent to which they will be required to play a part in the validation process. For example, if material certification is required for equipment components, these must be ordered from the supplier s own stockholders with the raw materials, and cannot be obtained retrospectively. 

List of other deliverables to be produced (e.g., project life-cycle documents such as control charts) and quality criteria... 

Assessments are only as useful as the available information (opinion and docnmentation) pertaining to the computer system under scrntiny. Snch information may be excessive, incomplete, inconsistent, or incorrect. Where there is insnfficient information to complete the GxP Assessment, a preliminary assessment may be condncted and reviewed when fnrther information becomes available dnring the later phases of the project life cycle. 

Is there a defined project life cycle What is it ... 

Changing Focus of Testing through Project Life Cycle... 

Prior to the start of the validation project, time and resources (and therefore money) must be expended to ensure that the requirements for the validation of LIMS are assessed from a regulatory and business perspective. This assessment should be executed as early as possible, preferably prior to purchasing LIMS. Many projects have had problems due to lack of appropriate funding, and consequently validation difficulties, due to the project personnel not understanding sufficiently early what needs to be done in the project life cycle. 

Data migration routines shall be qualified and test protocols completed with a data migration report approved prior to execution of the Cutover Qualification protocol. Figure 25.3 outlines the relationship between legacy and upgrade project life cycles. The Cutover exercise is designed to... 

FIGURE 25.3 Relationship between Legacy and Upgrade Project Life Cycles. 

Enables gaps in existing management system and documentation to be addressed early in the project life cycle... 

The following sections define the typical areas to be challenged by the audit team and the scope and content of documents produced at each phase of the project life cycle. 

Developers of applications that are intended to be used by organizations operating under the scrutiny of more than one regulatory body should ensure that the validation activities within their project life cycle encompasses the requirements of all these organizations. This will ensure that each of the intended end-user sites can successfully complete its on-site validation activity. Appendix 36A identifies some of the possible GxP business processes supported by marketing and supply apphcations. 

To complete the project life cycle, the Project Team should produce a Validation Report that aligns with the site Validation Plan. In addition to conhrming site validation activities, Validation Reports should conhrm the adequacy of all relevant central activities. A central Validation Snmmary Report (Quality Report) should be developed reviewing the adeqnacy and release of each appUcation/prod-... 

Established engineering methods and standards that are apphed throughout the project life-cycle to deliver appropriate, cost-effective solutions. indirect impact system... 

Contracts were awarded in March 2000, and preliminary EDPs were drafted by the technology providers in June 2000. Each EDP includes drawings and documentation, a preliminary hazards analysis, and projected life-cycle costs and schedules for the technology package to be implemented at a particular site. The final EDPs were released in December 2000. Experimental tests to support the EDPs were begun in June 2000, but some had not been completed when this report was prepared. Einal reports are expected to be published in mid-2001. 

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