Individual assessment - Practical application project

Using the following Medical Case Study below, you need to prepare:

1. Feasibility Analysis
- Technical Feasibility
- Economic Feasibility
- Operational Feasibility

2. Requirement Specification
- Project Scope
- Project objectives
- Functional Specification
- Non-functional Specification
- Project constrains
- Project Work Breakdown Structure

1. INTRODUCTION

1.1 Scope of Project

The Medical Affairs Department currently process medical enquiries manually. A Medical Enquiries Database is required to assist the staff in their daily work and allow them to efficiently and rapidly respond to medical enquiries.

The proposed system will do this by:

- providing easy access to past enquiries and their researched responses.

- providing easy access to reference information.

- allowing the users to rapidly construct written replies.

- providing a statistical analysis of medical enquiries previously received.

1.2 Company Overview

An important role of the Medical Affairs Department is to answer medical enquiries concerning Medical products. Medical enquiries are usually received from internal customers such as representatives, as well as external customers including doctors, retail and hospital pharmacists, drug information centres, consumers and others. Medical enquiries may be received via telephone, fax, letter or in person and can range from very simple questions which can be readily answered over the telephone to very complex enquiries which may require many hours of research in order to formulate an appropriate response.

With the merger of two Pharmaceutical companies, the Medical Affairs Department are now required to answer a greater number of enquiries for an increased portfolio of products.

1.3 Current Business Environment

The current system for recording the receipt of and reply to medical enquiries is a paper based system. The system is both time consuming and inefficient due to records of previous enquiries and reference information not being easily accessible. This makes the task of supplying information even more difficult for Medical Associates answering enquiries for products that are not normally within their area of expertise (for example when rostered to take calls received via the toll free telephone number).

When an enquiry is received, details of the enquiry are written on an Enquiry Report Form. A Medical Associate may provide an answer to the enquiry using their previous experience and knowledge of the product and either provide the information directly over the telephone or if requested, construct a written reply; When constructing a written reply, a Medical Associate would typically manually search for the appropriate "standard letter", transfer the address information from the Enquiry Report Form and then print the reply. (A "standard letter" is, in the context of the above text, a MS word document that contains information relating to a specific subject for a specific product. While the document is called a "standard letter", the information in the "standard letter" may also be adapted to construct a memo, a fax or a letter as required). Details of the reply provided are transcribed manually to the Enquiry Report Form which is then filed according to product.

Where the Medical Associate is not familiar with the appropriate answer to an enquiry or there is no suitable "standard letter", the Medical Associate will manually search a range of alternate sources of information such as past enquiries, consumer product information CPI's), compliance guides, product information (Pi's) foreign product listings, textbooks, registration dossiers or range of literature databases. The number and type of information sources used will depend entirely upon the nature of the enquiry. Once the appropriate information has been located, the response is prepared (as a MS word document). Again the Enquiry Report Form is completed and filed for future reference.

The Medical Affairs Department also monitor the number, importance and type of medical enquiries received and a range of other associated parameters (e.g. source of the enquiry, the mode by which the enquiry was received etc). This is also a paper based system where Medical Associates manually record a range of parameters, collate the data and transcribe it into Excel spreadsheets to generate tabular and graphical reports.

The main deficiencies of the current business environment are summarised below:

- It is extremely difficult and time consuming to locate an Enquiry Report

Form (historical data) pertaining to a specific previous enquiry.

- Reference information pertaining to a specific enquiry cannot be located quickly.

- "standard letters" become obsolete as there is no systematic review and update of them.

- enquirers often cannot receive an immediate verbal response due to the Medical Associate being unable to quickly target the required historical data and reference information if it is outside their current area of specialisation.

- Medical Associates are forced to provide an increased number of written replies in place of verbal reply's due to the inability of the Medical Associate to quickly target the required historical data and reference information.

- There is duplication of effort and expense as Medical Associates review reference information for enquiries that have been answered previously due to difficulties in locating a specific previous enquiry and response.

- A significant amount of time and resource is required to collate and generate statistical data on the number and type of medical enquiries received.

1.4 Future Business Environment

It is proposed that a Medical Enquiries Database be used to address the inefficiencies outlined above. The diagram on the following page together with the following text passage, aim to describe how it is envisaged that the future business environment would operate and highlight the benefits of the use of such a database.

It is envisaged that when an enquiry is received, details of the enquiry will be recorded on the database. The Medical Associate may then search the database for either historical data or "standard letters" by entering one or more search criteria. For example, a Medical Associate may request from the system a list of all the Zantac enquiries received during the last 12 months or request a list of all "standard letters" that contain the words "Zantac and side effects". Once an appropriate past enquiry or "standard letter" has been identified, the information can be provided immediately to the enquirer over the telephone. If required, this may be further supplemented with a hard copy of the required information which can be quickly printed from the system as it automatically merges together enquirer address/mailing details and the required information.

Should the system not contain information pertaining to a particular question, only then will the Medical Associate utilise other sources of information. Ideally, information such as such product information sheets (Pi's), consumer product information sheets (CPFs), compliance guides and foreign product lists will also be held as electronic copies in the database. Failing this, only then will the Medical Associate need to carry out an extensive literature search via text books, registration dossiers and a range of literature databases. Once the appropriate information is found, a response is prepared which is held on the database for future use.

With all enquiries now held within an electronic database, the Medical Affairs Department will also be able to perform statistical analyses of the enquiries received using a large range of criteria without the need for manual collation and transcription of data. This information could then be used by the sales and marketing force to assist in determining market direction and the effectiveness of information provided to medical professionals. For example, a report detailing the type of enquiries received for a product, could provide an early indication of market interest, direction or concern. (Examples of an enquiry type may include an enquiry related to an adverse event, an enquiry related to use of a product during pregnancy, an enquiry related to a comparison between Medical product and a competitor product.)

The main business benefits of implementing such an information management system are summarised in me following section.

1.5 Business Objectives

The business objectives of the system can be summarised as follows:

- Increase the number of enquiries that can be answered immediately over the telephone.

- Decrease me time taken to prepare written responses.

- Decrease the time taken to locate appropriate historical data and "Standard letters".

- Decrease the time taken to prepare a statistical analysis of enquiries Received.

- Increase departmental efficiency, freeing up resource for other activities.

- Increase utility of the data provided to the sales and marketing areas.