Business requirements

An API project is created when a need arises through one or more of several areas. Some examples include (1) new product introduction, (2) regulatory requirements, (3) existing product capacity shortfalls, and (4) process improvements. Any one or combination of these areas can generate the need for a new capital investment. 

We will focus on the requirements of engineering and construction of facilities for a new API introduction. This is the most difficult and complex task because the technology is untested on a commercial scale and there are technical assumptions with the associated risks that must be taken. Assuming the product and the process are untried at commercial scale, there may be unforeseen issues with start-up and 

A benefit for the readers is the ability to utilize this strategy for other process improvement or regulatory-driven projects. The steps are similar if not the same (the major differences are associated with the business and engineering analyses for the new API). 

An API Manufacturer Will Focus on the Appropriate Level of New Capacity 

Market projections will indicate required volumes of the new API. Unfortunately, market projections can vary widely. Manufacturing capacity for a new API facility is expensive to build, maintain, and operate. It is important to properly size the production processing equipment and supporting facilities. A proper engineering approach will incorporate the ability to expand a production facility or equipment train(s) to allow for future expansion for potential volume 

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Businesses require funds for day-to-day operations ( working capital ) and for expansion by acquisition and for the provision of plant and machinery, buildings, etc. Most working capital needs are normally (and should be) met from the company s own cash generated from its own operations. Indeed, the need to meet this criterion serves as a discipline upon the company s standard of cash management in relation to credit control, payment of suppliers, etc. 

Short development and release cycles (days or weeks instead of months) allowing fast response to changing business requirements, feedback from users and bugs, and continuous integration and testing of software revisions... 

A further constraint, traditionally not so high on the list, is the primary thrust of object-oriented and component-based design. This is to ensure that the finished system not only works but also can be changed easily to meet changing business requirements. 

Most project risk comes from two sources business requirements and technology infrastructure. It is common for a project team to evaluate complexity based mostly on the business requirements—the problem domain itself—and vastly underestimate the effort it will take to implement all the plumbing and supporting pieces that are not domain-specific. 

An object-oriented design according to these principles can be fully traceable from business requirements through to code, whether or not the correspondence is direct. 

There are useful mles of thumb for finding objects, attributes, and actions. Looking through existing documents (business requirements, user manuals, and so on), map nouns to object types, verbs to actions, static relationships to associations, rules to static and dynamic invariants, and variations to subtypes or other refinements. 

The Code of Practice Panel consists of members of the Prescription Medicines Code of Practice Authority and meets as business requires to consider complaints made under the Code. 

The Code of Practice Appeal Board meets as business requires to consider appeals under the Code and any other matter which relates to the Code. The Appeal Board receives reports on all complaints which have been submitted under the Code and details of the action taken on them. 

OSHA is responsible for regulating the workplace environment. The site has information on current standards and business requirements. 

This section will discuss the importance of defining business requirements to ensure processes comprising the QMS are designed to support the enterprise, integrated into a quality plan, sufficiently defined to provide adequate resolution and are transferable and scalable throughout the enterprise. 

To keep such business requires a full understanding of the customer s plant. Plus the provision of the highest quality of technical service, but as appropriate to customers needs. 

The overview in Table 1 holds, in principle, for any type of chemical industry. Additionally, different types of chemical industries may have different focuses, depending on their starting position and on their business requirements. Knowledge of the perspectives helps in determining the main cost drivers from the fist given in Table 1 and helps therefore in finding the starting points for process intensification studies. Table 2 presents an overview of some of the main types of chemical industries and the specific demands they posed on process intensification when applied in these industries. A distinction can thus be made between ... 

Change requests can result from both planned and unplanned events. Planned events can be scheduled, and can be the result of a planned expansion in business requirements. Emergency or unplanned events can result from software or hardware problems that prevent the application from performing its defined tasks. 

The specification names used here are one example, but there are many ways to refer to the same documents. The URS might instead be called the business requirements specification (BRS).The FRS might be functional specification (FS) or the system requirements specification (SRS). The DDS might be a design specification (DS) or an engineering specification (ES). The intended purpose of the specification must be delineated in the document to avoid confusion. 

Determining the best of these options for your organization will be influenced by the types of submissions to be transmitted, infrastructure capabilities, and business requirements. 

Dr. Bill Coleman, for several chemical steps in Syntex s synthesis of the oral contraceptive chlormadinone. With Haldor Christensen, sodium dispersion chemistry led to a superior process for the manufacture of the Eh Lilly herbicide, diphenamid. We devised novel patented chemistry, with the inspiration of Dr. Martin Hultquist, for the manufacture of DDQ. The list could go on and on, but the essence is that in Arapahoe we became chemical process development chemists. We learned that there were no such chemists as steroid chemists, organometallic chemists, heterocyclic chemists, and so on. There are only process development chemists, capable of synthesizing anything. Being scientists in a small company we also learned to accommodate other disciplines and business requirements in creating our chemical processes. 

The money value of world dye production is actually extremely small, corresponding in 1913 ( 500 million francs) to less than one-tenth of the value of wool production, less than one-fifth of cotton production, and about one-fifth of rubber production. Dye manufacturing was a highly competitive business, requiring expensive factories, and the energy, intelligence, and perseverance put into this industry is without parallel. 

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. 

Definition and documentation of the business requirements for LIMS is the first step in the implementation process. These requirements are not system specific and define, at a high level, what LIMS will be expected to do for the business. The business requirements are used in defining the system requirements in the supplier selection process and in the financial justification for the system. The business case will normally be based on the ability of the LIMS to ... 

The justification to senior management that LIMS is a cost-effective solution. These Business Requirements will be the basis for applying for funding for purchase and implementation of the application. The owner of LIMS must understand the benefits and drawbacks of implementing LIMS prior to purchase the requirements definition is the only time in the project that it can be achieved at a reasonable cost. 

Requirements Definition Business requirements and business case development... 

Procedural controls should be established in order to manage the ongoing snpport and maintenance of the IT infrastructure. This procedural framework is critical in keeping the IT infrastructure in a state of control, the objective being the maintenance of a continnons state of compliance as the IT infrastructure evolves to meet business requirements. 

The treatment of infertility in either sex is a highly specialised business, requiring a detailed understanding of reproductive physiology and analysis of the cause. 

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