Project technical requirements

The International Conference on Harmonisation (ICH) of technical requirements for the registration of pharmaceuticals for human use was established in 1990 as a joint regulatory/industry project to improve, through harmonisation, the efficiency... 

Step 2 Technical requirements Determine the specific technical requirements for the new method and/or analyzer that will ensure that it captures the previously determined business value. This is also done jointly by the customer and the project manager. Avoid nice to have and focus on what is necessary. Technical requirements may include accuracy, precision, specificity, turnaround time, response time, robusmess, maintenance needs, etc. They should be focused on what the analyzer needs to do (e.g. determine the concentration of component X with 1.5% relative precision, once a minute, in a corrosive process stream at 80 °C), not how it will be done. Issues that need to be considered in setting technical requirements are discussed in Section 15.2.3. 

Step 8 Method or analyzer qualification Qualify the method on site that is, assess the ability of the method as practiced to meet the original technical requirements such as speed, accuracy, and precision. This is best done jointly by the project manager and the receiver (who is the ultimate owner). 

Note It is assumed that if the analyzer meets the previously agreed-upon technical requirements, it will then deliver the agreed-upon business value. Some companies may require that this be verified, for example, by tracking the savings over a specified period of time, and the results included in the project closure documentation. 

ICH home page. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a unique project that brings together the regulatory authorities of Europe, Japan and the USA, and experts from the pharmaceutical industry. 

As valuable as Mann s contributions were, the public health/right to health project now requires us to reduce collective vulnerability, to increase communal public health knowledge, to mobilize material, technical, and psychosocial resources on a massive scale, and to provide pragmatic and proportionate support to communities overburdened with disease and on the verge of collapse. 

People often ask for an example of a detailed project plan. Working out a specific project plan requires in-depth knowledge of a technical system, however. As each system is different, Figure 3 can only show a general overview of a project plan. 

This is intended as an entree and as a focusing exercise to prove to busy people that there is mutual interest in cooperating. It is also useful to concentrate on one or two good examples and demonstrate success. Internally to the company, I have learned from experience that someone in the company who really cares about the project is required. For example, it is clearly a waste to fund a specific university because one of our employees was an alumnus but had no technical or business interest in the results. After writing the check, we had no other close ongoing relationship with the research until it was time for renewal. 

Another important planning document is the Laboratory Statement of Work, which is based on the SAP requirements for laboratory analysis. The Laboratory SOW summarizes project analytical requirements and serves as a technical specification during the laboratory selection process. The project team sends the SOW to several qualified laboratories for the preparation of a price proposal. At a minimum, the SOW should include the following items ... 

The business objective to be met by the computer system is expressed in a URS. This must provide a firm foundation for the project. A URS may exist as a single document or as a suite of documents. Supplementary documentation might include Business Requirements and Technical Requirements. However, the requirements are collated if they are not precise, concise, and complete, major problems appearing later in the project are almost a certainty. 

Potential bidders must be screened thoroughly to determine their technical competence as well as their organizational capability and/or willingness to meet project specific requirements, size fit, construction approach, etc. Contractors should not be placed on the bidders slate unless they are considered fully capable of performing quality work within the criteria established in the project execution plan. The criteria are the responsibility of the Project Manager, who must consider, as a minimum, the following factors ... 

This article summarises an integrated EPC/SPC methodology developed by Matos (2006) as a doctoral research project. The main goal was the development of a methodology that could be tested and applied to a real case study. Additionally, it should also be adjustable to other industrial processes with similar technical requirements. 

Summarize a recent article from a technical publication which describes a project that required soil stabilization. Were permanence or safety factor mentioned in the article Were parts of the technical description too vague to be of help in doing similar work In what areas would you have liked to see more detailed data ... 

Partly as a result of business constraints on research, many fine chemical processes are a long way from optimum, especially when compared to bulk chemical processes, in terms of yield, productivity and effluents. Important improvements in competitiveness could be achieved by development of new catalysts. Due to complexity, development of new catalysts generally requires time, and the industry generally prefers the use of old classical methods that are well known and require a short development time. The three technical requirements for a new catalytic process to be industrialised are the following 1) The chemistry must be already well advanced at the start of the project so as to fit with the timetable, 2) The chemistry must be easily adaptable to the existing industrial plant (with little modifications), 3) The chemistry must provide a breakthrough in terms of economics and effluents compared to existing processes. 

In coordination with programs and projects, to establish or approve the technical requirements and ensure they are enforced and implemented in the programs and projects (ensure the design is compliant with the requirements). 

Experience of fabricator/supplier (for the project) is professionally adequate for meeting aU technical requirements. 

The enterprise analyzes and compares the established requirements baseline against enterprise and project constraints to ensure that the technical requirements correctly represent, and stay within, enterprise and project policies and procedures, acceptable risk levels, plans, resources, technology limitations, objectives, decisions, standards, or other documented constraints. 

Furthermore, additional concepts including operation for launch, deployment and servicing was elaborated with cost trade-offs. The conceptual design was refined with costs and requirements for detailed design, development and con-stmction were identified. Finally, the implementation of the system architecture has been more impacted by technical requirements rather than the cost projections [74]. This phase was characterized among others by the following activities ... 

Interdisciplinary. Projects often require input from a variety of technical fields, use many forms of communication, and profit from the creative arts. 

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