Please complete the sections 5 to 10 in the document attached "Name - Final Project File_Himateja" Sections 1-4 are completed and you may use that to get an idea of what the plan is about.  Instructio

< Implementation of Intake Tool at Shire Pharmaceuticals >

< PMGT 699 – Applied Project Management>

Prepared By

<Himateja Nagabhyrava>

<08/09/2019>>

1. Executive Summary

1.1 ..Introduction………………………………………………………………………

1.2 .. Purpose………………………………………………………………………….

1.3 .. Scope……………………………………………………………………………

2.Project Overview 7

2.1Project Description 7

2.2Problem Statement 7

2.3Goals 7

2.4Project Background 8

2.5Product Objectives 8

2.6Assumptions, Constraints and Dependencies 9

2.7Project Deliverables 9

2.8Schedule and Budget Summary 10

2.10 Definitions and Acronyms 11

3.Stakeholder Register 12

4.Schedule Component 13

5.Resource Plan with RACI 16

5.1Overview/Purpose 16

5.2 Resourcing Strategy & Assumption 16

5.3 Resourcing Development 16

6.Risk Management Plan 17

6.1Review of Risk Management Plan 17

6.2Risk Identification 17

7.Communications Plan 18

8. Procurement 22

10. Integrated Change Control 27

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1. 1. Introduction

Shire Pharmaceuticals plays an important role in the generic drug development within the Pharmaceutical and Biotechnological industries. The key component of the success lies on successful delivery of the drugs via research and development. IT enterprise group within the Shire pharmaceuticals is responsible for the controlled submission of these drug development projects to regulatory bodies. As a pharmaceutical company, these submissions are the key step to initiate projects within the company and successful regulation of these information keeps the company confidentiality vs the way these projects are handled.

1. 1. Purpose

The purpose of this project is to implement an intake tool for Shire pharmaceuticals. The implementation will be a new installation as there have never been an intake tool in this organization. This might mean that the computer systems will be upgraded with the required resources to help in establishing the pathway through which the intake tool will be installed. Shire Pharmaceuticals seeks to have a system in place that will protect the information of the company which will be done through using the Intake tool, processing the Information and getting it to the regulatory authorities.

The implementation will Involve:

An established intake process that will assist the safety team to get the information easily and forward it to the regulatory authorities.

Intake tool acting as a funnel, giving the organization full insight of what is happening in the organization, thus having a single truth.

The intake tool is essential to Shire Pharmaceuticals as it will help in creating a system that will protect the information of the company. Whereby it will be crucial in application of a patent.

1. 1. Scope

The scope of Intake Tool applies to version 1.0 that will be used by Shire Pharmaceuticals to produce regulated project controlled environment and transfer. Intake Tool is hosted by the vendor (IQL) using Microsoft Azure datacenters and delivered to Shire Pharmaceuticals via SaaS model.

The following modules are in scope:

• Publishing Module

• Submission Planning Module

• Commitments and Correspondence Module

• Viewer Module

The following are out of scope:

• Registration and Tracking

1. 1. Project Description

The project focus is to create and intake tool at SP. Similar companies in the same industry have developed or are in the way of developing intake tools as it has its own benefits. In addition to that this an organization requirement to improve the normal data to day functioning of the company. The process of management of the underlying projects is what pushed for the implementation of such a tool as and obviously the need to have the information ready for the regulatory team. This means that SP will require, IT expertise and new software for the development of an intake tool, which is scheduled to be done in 6 months. Shire Pharmaceuticals will be introducing a new system that will enable them to be competitive in the new environment.

1. 1. Problem Statement

Shire Pharmaceuticals handles the projects through smartsheets. These smartsheets are then transferred to ServiceNow. The transfer is insecure, and the data is not appropriately represented when transferred. The loss of data while transfer is proportional to creating a new project within the ServiceNow. Hence, the company decided to move onto Intake Tool and decommission Smartsheets

1. 1. Goals

Shire Pharmaceuticals have various projects that are in place, these projects go through the same system in this organization without proper control. In an organization such as this there might multiple projects taking place at the moment, the goals of the Intake basically:

Business Goal 1: Security

• Specific = Adding Regulatory measures

• Measurable = Limit the share capacity of information with users within the company

• Attainable = Creating groups that require special access to a folder in which the information is stored and controlled

• Relevant = Having security measures shall allow only limited personnel to view this information and to keep track of who is able to access the folders.

• Timely = This must be done within 6-month timeframe.

• Project Objective 1.1: having a inbuilt organization tool will help, in putting regulatory measures in protecting the information of SP.

Business Goal 2: Control of the System

• Specific = Adding intake tool as a integration

• Measurable = Projects are available to SeviceNow via Intake tool and the data is qualified

• Attainable = integration of Intake tool with ServiceNow will allow controlled flow of projects

• Relevant = It will allow the track of influx of projects that are directed to Intake Tool and hence keep audits of records

• Timely = This must be done within 6-month timeframe.

• Project Objective 2.1: The Intake Tool will help in developing a system that will assist in controlling the projects taking Place in SP. Through work Intake process.

1. 1. Project Background

The Intake Tool system delivered by IQL will be used by SP IT Enterprise Group to produce Controlled Project delivery and transfer. The Intake Tool software was validated because it is used in the development of Controlled Projects which must comply with specifications as per ICH-M4 CTD and ICH-M2 EWG. ARIM is used in the compilation of the draft’s submissions. The draft compilations produced by Intake Tool are used in generating a submission but are not required to be maintained under a predicate rule, nor will they be electronically submitted from Intake Tool through the electronic gateway, and therefore are not considered to be electronic records as per 21 CFR Part 11. The creation, modification, maintenance, archival, and transmission of records to be submitted as part of the final/approved guidelines. Compilation occurs outside of the Intake Tool system. The submission files are only considered to be electronic records once they have been approved by the Enterprise submission lead and submitted to the FDA.

1. 1. Product Objectives

1. Having an inbuilt organization tool will help, in putting regulatory measures in protecting the information of SP.

2. The Intake Tool will help in developing a system that will assist in controlling the projects taking Place in SP. Through work Intake process.

3. Helps Track of projects and limited share capacity

4. Allows Controlled flow of projects through Intake Tool to ServiceNow

5. Easy interface to use and allow share instantly

1. 1. Assumptions, Constraints and Dependencies

Constraints:

• Constraint 1: system failures due to first installation of the Intake tool.

• Constraint 2 : safety team training might be challenging.

• Constraint 3 : there will obviously be downfalls, hence testing is important before implementation.

Assumptions

• Assumption 1: the project will use less time to be completed.

• Assumption 2: Shire Pharmaceuticals have the required infrastructure.

• Assumption 3: the Project Manager will come form Shire Pharmaceuticals, because the PM will the best insight on what is the need of the company.

1. 1. Project Deliverables

1. 1. Schedule and Budget Summary

4.1 Purpose/Overview

Schedule is a way to look the processes into tasks, schedule allows the users to investigate the tasks and help them keep track of the tasks. Shire pharmaceuticals has a group names IT enterprise group that usually handles all the projects within the company. The IT enterprise associate sits with the IQL lead manager to discuss the project and its details. They decide the project tasks and milestones based of a series of meetings with all the parties that’s shall be involved in the project. Both IQL and shore then look at the possible risk options with the laid tentative plan. The path to get success is assessed, longest, shortest and easiest etc.

When the desired path is designed, both IQL and Shire finalize the schedule and then develop the plan. During this development they also consider all factors that need to be considered within the elements of developing the project.

Once the design is developed, the linkage and sequencing is assessed to make sure that the right amount of activities are distributed in each phase ahead of the finalization to limit the loss of budget and time.

Task Dependencies:

1. Finish to Start (FS)

2. Finish to Finish (FF) 

3. Start to Start (SS)

4. Start to Finish (SF) 

4.2 Schedule Baseline

4.3. Schedule Control

The approved schedule baseline will be changed only through the formal change control process and only after the impact on the project constrains has been assessed.

[Define the resourcing strategy for the project. How will resources be acquired and released from the project?]

[When estimating the resources on the project, have you made any assumptions about those estimates?]

1. 1. Review of Risk Management Plan
   2. Risk Identification

6.3 Risk Analysis

6.4 Risk Monitoring Plan

7.1 Overview/Purpose

The purpose of the communication plan is to ensure the Project Management Improvement Project provides relevant, accurate, and consistent project information to project stakeholders and other appropriate audiences. By effectively communicating the project can accomplish its work with the support and cooperation of each stakeholder group.

The communication plan provides a framework to manage and coordinate the wide variety of communications that take place during the project. The communication plan covers who will receive the communications, how the communications will be delivered, what information will be communicated, who communicates, and the frequency of the communications.

The following outlines the targeted audiences, the key communication messages to be delivered, and the method for delivering the information, the communicator, and the frequency of the delivery.

7.2 Communication Message and Delivery (Matrix)

7.3 Communications Guidelines

7.4 Escalation Process

9. Cost

9.1 Introduction

[The purpose of this document is to provide general content of a Cost Management Plan and to describe submission required in Microsoft Project format (.mpp file).]

Cost Management Plan

[A cost management Plan defines cost baseline, modifies it whenever necessary, and uses it for monitoring and controlling cost. A project cost management plan generally includes descriptions, procedures and responsibilities for items such as Costs included, activity resource estimating, cost estimating, cost baseline, budget determination and cost control.]

9.2 Estimate Cost

[Estimate Cost is a process of developing an approximation of monetary resources needed to complete project activities.]

9.3 Contingency Reserve Project Purpose or Justification

[Contingency reserve is money assigned to the project and allocated for identified risks for which contingent responses are developed. Generally, how much money is reserved and its rationale are included here.]

9.4 Budget

[Once the project costs or cost baseline is determined, a time-phased project budget is developed. Project budget shows how the project cost will be incurred by appropriate periods (months, weeks, quarter, etc.) during project performance period. Describe how your budget is developed.]

Cost Control and Monitoring

[The approved project budget with contingency reserves serves as a baseline for project control. This section usually include project approach to monitor actual versus planned performance, approach ( e.g. Earned Value analysis), and how any cost changes will be managed.]

9.5 Performance Monitoring

[Describe your approach to monitor planned versus actual performance and matrices that will be used]

9.6 Project Reports

[Include name and description of 2 to 3 reports that you plan to use for performance monitoring, status reporting or other reports. These are the reports for which you will be submitting a Microsoft Project mpp file. See section below. ]

9.7 Cost Change Control

[Describe briefly how any changes to the cost baseline will be administered and implemented.]

Microsoft Project Deliverables

9.8 Project Budget

[Include your project WBS (in .mpp format) that represents your project cost. Ensure that contingency reserves as a separate line item. The report submission is in Moodle]

9.9 Microsoft Performance Report

[Include report name and describe how the report will be used]

9.10 Microsoft Performance Report

[Include report name and describe how the report will be used]

Example – Communications Plan v1.0.1 Page 26