Implementation of Veeva QMS at Ironwood Pharmaceuticals Essay
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Implementation of Veeva QMS at Ironwood Pharmaceuticals Essay
<Implementation of Veeva QMS at Ironwood Pharmaceuticals>
<PMGT 699 – Applied Project Management>
Prepared By
<Srinivasa Shiva Theja Yadlapalli>
<07/27/2019>
- Executive Summary
1.1 ..Introduction………………………………………………………………………
1.2 .. Purpose………………………………………………………………………….
1.3 .. Scope……………………………………………………………………………
- Project Overview
2.1 Project Description
2.2 Problem Statement
2.3 Goals
2.4 Project Background
2.5 Product Objectives
2.6 ..Business Objectives……………………………………………………………..
2.7 ..Milestones……………………………………………………………………….
2.8 Assumptions, Constraints and Dependencies
2.9 Project Deliverables
2.10.. Project Success Criteria ………………………………………………………..
2.11..Schedule and Budget Summary
2.12..Evolution of the Plan
2.13 ..References
2.14 Definitions and Acronyms
- Stakeholder Register
- Schedule
4.1 ..Purpose/Overview………………………………………………………………..
4.2 ..Schedule Baseline……………………………………………………………….
4.3 .. Schedule Control…………………………………………………………………
- Resource Plan
5.1 .. Overview/Purpose of the Resource Section ……………………………………
5.2 ..Resourcing Strategy & Assumptions….………………………………………….
5.3 .. Resourcing Development………………………………………………………..
- Risk Management Plan
6.1 .. Purpose/Overview………………………………………………………………
6.2 .. Risk Identification………………………………………………………………
6.3 ..Risk Analysis……………………………………………………………………
6.4 Risk Monitoring Plan …………………………………………………………….
- Communications Plan
7.1..Overview
7.2..Communication Message and Delivery
7.3..Communications Guidelines
7.4.. Escalation Process
- Procurement
- Cost
9.1.. Introduction
9.2.. Estimate Cost
9.3.. Contingency reserve project purpose or justification
9.4..Budget
9.5..Project and Monitoring
9.6.. Project Reports
9.7..Cost Change Control
9.8..Project Budget
9.9..Microsoft Performance Report #1
9.10..Microsoft Performance Report #2
- Integrated Change Control
1.Executive Summary
1.1 Introduction
Computer systems play a major role in the development and manufacturing of medical devices and drugs. The pharmaceutical industry is one of the highly regulated industries and thus increasingly relies on computerized systems to ensure consistency, reliability, accuracy, and ability to detect and reject invalid records. Computers perform several functions in pharmaceuticals. According to Bandameedi (2016), pharmaceutical companies use a computer to manage drug-related activities such as creating and modifying patient files, management of clinical trials, discovery and designing of drugs, and data storage and retrieval. The improvement in computer software and hardware has also helped pharmaceuticals in research publications and adverse drug events control (Bandameedi, 2016). Computer system validation (CSV) is, therefore, important in the pharmaceutical industry because it helps companies to maintain the required standard quality and adhere to pharmaceuticals guidelines.
1.2 Purpose
The purpose of this project is to Implement Veeva QMS in Ironwood pharmaceuticals. The implementation will focus on replacing the existing Veeva QMS in Ironwood pharmaceuticals with. Also, the computer system validation process will replace the paper system in pharmaceuticals with a new computer system. Veeva QMS implementation seeks to improve reliability, accuracy, and performance consistency of handling quality related methods within Ironwood pharmaceuticals. Quality Management System is essential for maintaining the quality of the medical devices and drugs and compliance with the pharmaceuticals guidelines.
The Implementation shall contain the following modules;
- Change Control (CC)
- OOS/OOT
- Product Complaints
- Deviations
- Audit
The above-mentioned modules help Ironwood Pharmaceuticals in;
- Managing Deviations within the controlled environment with a detailed Audit trail report for each step
- Manage Product Complaints in a unique designed process specific for Ironwood Pharmaceuticals
- Reduce Report handling time by in-built reporting capability that allows generating reports instantaneously
1.3 Scope
Deployment of Veeva QMS at Ironwood Pharmaceuticals Inc.’s facility (please, refer to Project Charter, Section 3, Project Scope Statement for complete details).
The Project Scope will be controlled and verified as defined in the present section of this document.
It is the responsibility of Veeva’ Project Manager to control the scope of this project.
Scope Control, and all associated change requests, will be managed according to the following Project Change Control Procedure.
All change requests must be sent to Veeva’ Project Manager. The project Manager will evaluate them together with Veeva’ technical team, if necessary. These requests will be evaluated versus their impact on the project in the following ways:
- If requests are considered within the current Project Scope (e.g. minor changes to configuration, additional document types, and changes in roles within Veeva QMS) and can be implemented without affecting the project schedule, they will be directly approved by Veeva’ Project Manager. Decisions will be communicated to Ironwood Pharmaceuticals Inc.’s Project Manager and activities will be scheduled in the Project Management Plan for implementation.
- If requests are considered within the current Project Scope but cannot be implemented without affecting the project schedule, they will be escalated to Veeva Director of Professional Services.
- If a change request falls outside the current Project Scope, it will be escalated to Veeva’ Chief Executive Officer CEO and to the technical team for evaluation and feasibility analysis. Decisions will be communicated to Ironwood Pharmaceuticals Inc.’s Project Manager and, if necessary, activities will be scheduled in the Project Plan for implementation.
2.Project Overview
2.1 Project Description
Veeva QMS Implementation consists in the deployment of the Veeva QMS software at Ironwood Pharmaceuticals Inc.’s facility. It comprises the configuration, installation and validation of the software and its features: Processes, Document, Train, Task and Setup. It also includes the training of Ironwood Pharmaceuticals Inc.’s resources in its usage, as established in the Project Scope statement of the Project’s Charter.
2.2 Problem Statement
The pharmaceutical industry is increasingly becoming modernized meaning that companies continuously adopt new technologies. New technologies are applied in designing and manufacturing of medical devices and drugs. Due to rapidly growing technology, new computer hardware and software are introduced into the market. Therefore, there is a need for pharmaceuticals to adopt new computer system validations to ensure that the new information technology systems fulfill the intended functions. Technology is an important facet in the pharmaceutical industry because it enhances the competitive edge of the companies. Also, computer system validation is part of the Food and Drug Administration (FDA) regulations. According to the Pharma Mirror (2016), the adoption of new computer systems in pharmaceuticals must follow FDA regulations and rules in their validation program. Failure to follow these regulations invites warning letters and inspection from the FDA and sometimes fines and legal actions. FDA has issued warning letters to several companies in the pharmaceutical industry for failing to adhere to CSV regulations. For instance, in 2018, FDA issued a warning letter to a Japanese Bio-Chemical Manufacturing Company for deviating from the current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) (Marcial, 2018). Therefore, the new computer validation implementation plan will help in addressing such problems in the pharmaceutical industry.
2.3 Goals
The QA Document Management group at Ironwood currently manages the lifecycle of approximately 800 GXP controlled documents and manages the training profile of approximately 150 employees resulting in approximately 3500 training records/incidences on an average each year. The current process is not electronic; therefore, the approval of documentation is performed manually (on paper). This requires extensive administrative overhead due to the compilation and distribution of paper records.
Through this implementation the company looks to:
- Facilitate document approval.
- Reduce document revision and approval time.
- Improve document management practices.
- Streamline, enhance and simplify document revision and approval of documentation.
- Reduce time spent archiving and retrieving documents and training records.
- Standardize training records management and recording of training activities electronically.
- Better control the “daily” monitoring of compliance in order to be ready for audits at all time.
- Improve communication between participants in the approval chain.
- Create a participative environment for revision and approval.
2.4 Project Background
The project focuses on the implementation of Veeva QMS at Ironwood pharmaceutical. Pharmaceutical and other medicine-related industries are increasingly becoming modernize and continue to implement new technologies; thus, there is an increasing need to ensure that these technologies accurate and safe to be used by companies with complying to Regulatory agencies. Several computer systems are being implemented by pharmaceutical companies to ease the process of designing, manufacturing, and distribution of medical devices and drugs. Some of the new software in the pharmaceutical industry includes a Quality management system. The implementation of the project is scheduled to take six months. Veeva QMS will replace the existing system, which has become outdated and inefficient in the current environment.
2.5 Assumptions, Constraints and Dependencies
Constraints:
- Constraint 1: The key users and stakeholders should learn to use the system before it is fully operational
- Constraint 2: training will cover all aspects of the systems, including safety and maintenance
- Constraint 3: system may contain unidentified pitfalls; therefore, the project should be tested before implementation. Also, the project is expected to be completed within six months
Assumptions
- Assumption 1: The main assumption in this implementation plan is that there is a challenge in the communication between different departments. It also assumes that departments would offer administrative support for the development and implementation of the project
- Assumption 2: A Project Manager is assigned to the Project on Ironwood’s side
- Assumption 3: Veeva QMS infrastructure requirements are met
- Assumption 4: Installation of Veeva QMS will be performed remotely.
2.6 Project Deliverables
Deliverables Available Acceptance Criteria Project Charter* August 2019 Approved by BO, IT and QA Project Plan* August 2019 Approved by BO, IT and QA Project Management Plan* September 2019 Approved by BO, IT and QA Project Status Reports* Every Week** Approved by BO, IT and QA Project Change Request* October 2019 Approved by BO, IT and QA Project Closure* January 2020 Approved by BO, IT and QA Veeva QMS Software Configuration* November 2019 Approved by BO, IT and QA Client Environmental Compatibility Assessment* November 2019 Approved by BO, IT and QA Veeva QMS Installation and Configuration* December 2019 Approved by BO, IT and QA User Requirements Specification* December 2019 Approved by BO, IT and QA Testing Protocol* December 2019 Approved by BO, IT and QA Test Scripts* December 2019 Approved by BO, IT and QA Requirements Traceability Matrix* December 2019 Approved by BO, IT and QA Validation Summary Report* January 2020 Approved by BO, IT and QA *Note – All deliverable dates are currently adjusted to the month available and refer to Schedule Baseline in Section 4.2 for more accurate details on date availability for individual document.
**Note – Starting from 1st Week of August.
2.7 Schedule and Budget Summary
Aug 2019- Dec 2019 January 2019 FY Total FY Total Initiation Phase Develop/Initiate Project Charter 5,000 5,000 N/A N/A Planning Phase Initiate Validation Activities 25,000 25,000 Execution of Validation 20,000 20,000 Training PO 10,000 10,000 N/A N/A Configuration Phase Software IQ. Initiate/Execute 10,000 10,000 N/A N/A Software OQ. Initiate/Execute 10,000 10,000 N/A N/A Migration Activities Prepare Migration/Execute 15,000 15,000 Migrate Completion N/A N/A 25,000 25,000 Project Close-out Phase 5,000 5,000 Other (Hosting, Interface, Maintenance and support) 35,000 35,000 N/A N/A Total 105,000 45,000 Total Project Budget $150,000 2.10 Definitions and Acronyms
Term/Abbreviation Definition GxP Good (Lab, Document, Clinical) Practices QMS Quality Management System OOS/OOT Out-of-Specifications UAT User Acceptance Testing QA Quality Assurance 3.Stakeholder Register
Stakeholder Role Responsibility Amount of Influence Impacted by Notes Lisa Jazon Quality and Compliance Evaluating incoming Change Controls High New implementation of the System and change of procedure Wants to add all possible values that are existing and would like to review the meta fields before launch Billy Dunder Senior Legal Supervisor Maintaining Legal regards and Processing complaints Medium New process-oriented procedure around receiving and evaluating complaints Wants to be trained as early as possible and requested to be on all configuration meetings. Abhilasha Sharma Training Supervisor Assigning training and maintaining training documentation for all employees Low New Module implementation Requested to be included in the meetings involving configuration of training. Marcel Audit Supervisor Audit assistance and replies to observations High New procedure and templates for Audit responses Interested in knowing the new process and wants to help in developing the procedure. 4.Schedule Component
4.1 Purpose/Overview
Communication is effectively done using a certain documentation that helps track of the items that help complete the project. Project scheduling is one of the best ways to do this. In the beginning, the project managers for both Ironwood Pharmaceuticals and Veeva QMS sit together with all the appropriate parties to discuss the activities that shall be planned for all the phases to comeplet the project. The project planning also involves the risk component which allows to arrange tasks that are ascertained to risk to move around and plan resources ahead.
In addition, project plan is scheduled using the longest path possible which covers all the risks components and help track the project all the way through and help in successful completion. Upon completion of listing all the tasks, the next step shall be to make sure that the sequencing of these tasks are appropriate. There shall be dependencies between tasks, these tasks follow these assigned sequences to track the work better and efficient.
Task Dependencies:
- Finish to Start (FS): This is the most common dependency. When tasks A and B have an “FS relationship,” task B cannot start until task A finishes.
- Finish to Finish (FF): When tasks A and B have an FF relationship, task B cannot finish until task A finishes.
- Start to Start (SS): When tasks A and B have an SS relationship, task B cannot start until task A starts.
- Start to Finish (SF): When tasks A and B have an SF relationship, task B cannot finish until task A starts.
4.2 Schedule Baseline
Tasks Description Creation of the Activity List and attributes Both project managers from Ironwood and Veeva sit together with all the relevant members who are involved in the project to discuss the activities in each phase. These phases are divided based on the work done using waterfall method. All activities planned in each phase are also discussed along with the timelines and that all members involved in the project have agreed to those activities and are aligned with the phases it has been Estimation of activity resources Each activity is subdivided with levels of effort that takes to complete the task successfully. Level A is for task that take longer than 2 weeks and requires more hours to complete the task. Level B is much smaller and can be completed with less hours and takes less than 2 weeks to complete. Level C is described to be task which is easier and can be completed less than a week. Level D are tasks that require only approvals and do not take more than a day or two to complete. Activity duration estimates When the activities are planned, all the members together come with estimates based on how long will they take to complete also considering the external factors that depend on those particular dependencies Approval of the schedule baseline The Schedule baseline shall be approved by Both project managers from Veeva and Ironwood Pharmaceuticals. The internal approvals of both parties are done prior to approval of managers. 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.
Performance reviews Weekly meetings are scheduled between teams to discuss the effort and cost that has been used for the project. End of each month these meeting minutes are taken into consideration and projects managers from both Veeva and Ironwood Pharmaceuticals meet to discuss the overall performance of the team. Schedule control thresholds The planning of the project focusses on measruring the risk component when the plan is created. Usually, there is a 10% risk taken into consideration of activities that have some internal and external dependencies. Such activities are provided with 10% extra time. However, there is a high chance of unexpectedness in projects. And any risk that involves time to be increased by15%, project managers must meet to discuss the issue and approve it before it makes it to the plan. Schedule performance reporting Schedule performance shall be reported to the PMO every 1st week of the month after the Schedule performance meeting. This is a high-level meeting and only PMO and the Managers meet to discuss the performance and resolving any issues. 5.Resource Plan with RACI
5.1Overview/Purpose
The purpose of the resource plan is to provide clarity on the allocation of resources required to complete the project and ensuring that stakeholders have been assigned specific tasks depending on their responsibility, accountability, power, and interest. All the tasks involved in the implementation of the Veeva QMS should be assigned to the specific stakeholder who will ensure that it is implemented as per the project plan. Also, every activity in the project needs the resources assigned to it. Resources comprise personnel, money, equipment, and all other things that ensure successful completion of the project.
5.2 Resourcing Strategy & Assumption
The project manager from Veeva and Ironwood will be responsible for gathering all the resources required for the implementation. At the beginning of the project, the organization the project owner who is mandated the task of collecting resources and manpower necessary for implementation of Veeva QMS. The project owner establishes the project team in consultation with the validation steering committee. The validation project team, which is drawn mainly from the quality assurance and IT department is responsible for carrying out the primary activities outlined in the project plan.
The project team, under the leadership of the project owner, will facilitate the procurement of the systems and software. The team will also estimate and assign resources to all the activities listed in the project list. Some of the techniques that will be used in estimating the number of resources for each activity include expert judgment, alternative analysis, published estimating data, and bottom-up estimation. Expert judgment implies using the opinion of the experts to estimate the resources that are needed in the validation of the new computer system. The experts should be knowledgeable and have prior experience in a similar project. The alternative analysis means the project team will have to try different options of resource allocations while estimating resources using published data entail using journals, books, articles from other projects and applying them. On the other hand, bottom-up estimation involves breaking complex activities into simple tasks and allocation resources. However, this resource technique is tedious, expensive, and consumes a lot of time.
5.3 Resourcing Development
All the resources will be provided at the start of the project. The project owner will present the project budget the project sponsor who will then facilitate the provision of resources. The project owner is responsible for managing all the resources and ensuring that they are properly utilized. The validation project team is responsible for designing, implementing, and providing support to the after it has been launched. The input of the system vendor will also be required to ensure that the system functions properly without technical errors.
High Level Responsibility Assignment RACI Matrix – Ironwood Pharmaceuticals Team RACI ROLE PMO PM Business Owner IT Owner Ironwood QA 1 and 2 Ironwood Training Specialist Project Planning A R Project Management A R Project Status A R I I I I Software Installation A C C C Software Configuration A C C C Data & Document Migrations A C C C Validation A R R R Training A I C C R
High Level Responsibility Assignment RACI Matrix – Veeva QMS Team RACI ROLE CEO PM Veeva Configuration Specialist Veeva Solutions Architect Veeva QA 1 and 2 Veeva Training Associoate Project Planning A R C C C C Project Management A R Project Status A R C C C C Software Installation A C R Software Configuration A C R C Data & Document Migrations A C R C Validation A R R Training A R Legend:
R Respsonsible for Task Being Completed A Approves Task Deliverables C Consulted – Must be consulted before deliverables approved I Information – must be informed on status 6.Risk Management Plan
6.1 Review of Risk Management Plan
The risk management plan is a document in project management that project owners use to predicate risks, evaluate impacts, and establish appropriate response strategies. Risks refer to uncertainties that occur during the implementation of the project. These uncertainties can impact the project both positively and negatively. Negative risks cause harm to the project and must be prevented from happening positive risks create opportunities that enable the project to progress smoothly. It is important to note risks are unavoidable; therefore, project managers should devise proactive risk management strategies to maintain the impacts of risks at an acceptable level. The implementation of Veeva QMS should have a risk management plan to correct uncertainties. Establishing a risk management plan for the validation program is essential to the project because it reduces the cost of validation. The plan ensures that resources are dedicated to high-risk systems in the project. Risks are often categorized as high, medium, and low risk, and risk management requires proper planning and risk analysis during the inception of the project.
The risk management process helps the organization to deal with risks proactively, effectively, and in a way that will maintain risk exposure below the risk threshold. The risk management is vital in ensuring that the project achieves its objectives. Risks can either be threats as well as opportunities. Acceptable risk refers to a risk level that is deemed acceptable to the organization, staff, or community affected. Since risks cannot be reduced to zero, the project managers set risks levels that are acceptable to key stakeholders, including project sponsor and investors during the entire project life cycle. Therefore, the project manager must conduct both qualitative and quantitative risk analysis to understand better the risks that might face the project at different stages of development.
The risk management process also aims to engage all the key project stakeholders to develop a sense of ownership and encourage them to input their ideas that would help in reducing risks and steering the project towards realizing its objectives. All information regarding risk on the project will be communicated to the stakeholders promptly to enable the management to devise an appropriate strategy for alleviating risk occurrence. Risk management process enables project managers to focus their attention on the specific phases of the project where risks are more pronounced. Typically, there are four phases in a project life cycle; initiation, planning, implementation/execution, and closing phase.
The scope of the project involves project planning and organization of various aspects, including features of the project, timeline, and costs. It is important to document the scope of the project at the initiation phase to allow the project stakeholders to anticipate risks, costs, and other important aspects of the project. The project scope also provides an insight to the customers and the owner of what the product of the project will look like upon completion. It is important to involve the right stakeholders throughout various phases of the project to avoid confusion, which would jeopardize all project.
6.2 Risk Identification
Risk identification refers to the second step in the risk management process, whereby the validation project team helps in identifying and documenting potential risks that may occur during the implementation of the new computer system. For instance, the risk may arise due to a lack of communication between key stakeholders and validation project team. The lack of proper communication among different stakeholders in the organization leads to inaccurate requirements; hence derailment of the project. Different techniques can be used to identify potential risks in the computer system validation project. First, the project manager can conduct brainstorming sessions to identify risks. During brainstorming, stakeholders and project team members converge in a room where they suggest ideas of potential risks. Secondly, risks can be identified using the probability and impact matrix technique. The technique helps in identifying and ranking risks according to their likelihood of occurrence. Also, risks can be identified by reviewing the risk register. The risk register is a document that contains all potential risks, risk owners, and the status of the risks. Therefore, reviewing the risk register helps in identifying risks that were not identified during the inception of the project. Other risk identification techniques include analysis of the project’s constraints and assumptions and reviewing checklists.
6.3 Risk Analysis
After identifying potential risks in step two, the project manager conducts a risk analysis to establish which risks require immediate attention and which ones are less harmful to the project progress. According to McDowall (2005), risk assessment involves risk analysis and risk evaluation and utilizes available information to estimate the risks. Risk assessment outcomes are used to evaluate which risks responding to first and which risks to be accepted as less threatening. The risks level depends on the severity of the risks and impact on the project. Identified risks are also assessed for potential harm and probability of occurrence.
Risks are categorized as high, medium, or low. High risks are those uncertainties which have a highly harmful impact on the project and require immediate attention. These are risks that perceived to occur once per less a thousand transactions. Medium risks are those which occur once per thousand transactions while low risks involve uncertainties that occur once per ten thousand transactions. Low risks imply that they are unlikely to happen while medium risks have a moderate probability of occurring. Different techniques can be used to estimate the frequency of occurrence of risks in computer system validation project. These include hazard analysis and critical control points (HACCP), fault tree analysis (FTA), preliminary hazard analysis (PHA), FMEA, and failure mode, effect and criticality analysis (FMECA) (McDowall, 2005). In the case of complex computer systems, GAMP risk assessment methodology is appropriate. The classification of risk is done by plotting the probability of occurrence against the severity of the risk on the project. In the early phases of the validation process, all risks are allocated medium likelihood of occurrence but should be changed in the course of the project life cycle. The table shows a Boston grid for classifying risks according to FMEA.
The severity of the impact of the risk Risk Probability Low Medium High High Level 2 Level 1 Level 1 Medium Level 3 Level 2 Level 1 Low Level 3 Level 3 Level 2 6.4 Risk Monitoring Plan
Risk monitoring is an important process in the risk management plan. The main purpose of risk monitoring is to ensure that the organization fully implements risk response strategies. Also, risk monitoring helps in documenting the progress of the response strategies and their effectiveness and reports it to relevant stakeholders. According to Metheny (2013), risk monitoring verifies compliance with the response decisions and determines any changes that may affect the progress of the project.
Risk monitoring process in the new computer validation project will entail reviewing of various processes including control, access, and risk identification. The project owner will review risk management reports every month. The project team will identify and submit potential risks to project owner will, in turn, review and assign to the risk owner to act on it. The project owner will also use the probability matrix of occurrence to prioritize risks. Risks with a high probability of occurrence will be given the priority because if they have the highest on the project progress. The risks identified by the validation project team members are controlled as per the mitigation strategies agreed upon by the validation steering committee and the project owner. Throughout the project lifecycle, the root cause of the risks will be documented and updated on the risk register.
The table below shows the roles and responsibilities of various stakeholders in risk monitoring of the validation project.
Role Responsibilities Project Manager The main role of the project manager in risk monitoring is to review and analyze risks, establish mitigation plans, and initiate the implementation of the mitigation strategies. Validation project sponsor The project sponsor approves any changes in risk strategies in consultation with the project owner. Validation project team The project team monitors and identifies new risks on the course of the project progress. The project team also documents the effectiveness of the project team and reports any changes in the strategies to the project owner. Data migration expert Helps in laying down data migration infrastructure from the old system to the new system. 7.Communications 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)
Clear, complete, accurate, concise and timely communication must exist to ensure properly informed stakeholders.
The following table shows the communication activities, person responsible and frequency.
Activity Audience Purpose Frequency / When / Responsible Type/Method Working Sessions To be determined Gather information for Project Charter and Project Management Plan Before Project Start Date Veeva Project Manager
Meeting Distribute Project Charter Project Sponsor, Project Owner, and Project Super User. Obtain formal approval of Project and its scope Before Kick Off Meeting Before Project Start Date
Veeva Project Manager
Document distributed via hardcopy or electronically. Distribute Project Management Plan All stakeholders Obtain formal approval of Project Management Plan and inform stakeholders After Project Charter’s approval VEEVA Project Manager
Document distributed via hardcopy or electronically. Project Kick Off Meeting All stakeholders Communicate plans and stakeholders’ roles/responsibilities. Encourage communication among stakeholders.
At or near Project Start Date VEEVA Project Manager
Meeting Project Status Report All stakeholders Update stakeholders on progress of the project. Every 3-4 weeks VEEVA Project Manager
Distribute electronically Team Meetings Entire Project Team. Individual meetings for Sub-teams, Technical Team, and Functional Teams, as needed.
Review detailed plans (tasks, assignments, and action items). Weekly VEEVA Project Manager/ IW Project Manager
Meeting Sponsor Meetings Sponsor, CEO and Project Manager. Update Sponsor(s) on status and discuss critical issues. Seek approval for changes to Project Plan. As needed VEEVA Project Manager/ IW Project Manager
Meeting Audit/Review CEO and Project Manager Review status reports, issues, and risks. To identify and communicate potential risks and issues that may affect the schedule, budget, or deliverables. As Needed VEEVA Project Manager/ IW Project Manager
Meeting / Report Quarterly Project Review Project Manager and key stakeholders. Review overall health of the project and highlight areas that need action. Quarterly VEEVA Project Manager/ IW Project Manager
Meeting / Report Post Project Review Project Manager, key stakeholders, and sponsor. Identify improvement plans, lessons learned, what worked and what could have gone better. Review accomplishments. End of Project. VEEVA Project Manager/ IW Project Manager
Meeting / Report 7.3 Communications Guidelines
The project communication plan follows standard communication guidelines and procedures. Communications guidelines help in ensuring that communication goals and objectives are met. Usually, communication guidelines are specific to the method of delivery. For instance, when sharing a message in a meeting, the agenda of the meeting should be published before the meeting and pre-meeting requests. The attendees of the meeting should be notified about the meeting two weeks earlier and provided with meeting agendas. This will allow team members to prepare adequately for the meeting. Also, the meeting facilitator should ensure that the attendees arrive at the meeting venues at five minutes before the meeting starts. The facilitator should ensure that the meeting starts and ends within the schedule and does not deviate from the agenda. Additionally, all necessary people should be invited to the meeting. For instance, for a risk identification seminar, representatives of all groups and departments affected by the new computer system validation should be invited to the meeting.
On the other hand, when delivering a communication message through Emails, the project owner should ensure that the subject line of the email or memo is precise and clear. The body of the message should identify the issue in the introduction. Also, the attachments in the email should be named clearly, and the project owner must ensure that all email communications are signed.
7.4 Escalation Process
Any escalation of issues shall be raised to the department manager, who then escalates to the Project Manager. The manager is responsible to resolve the issue. If the problem persists, the project manager must report it to PMO and get all stakeholders involved to resole the issue.
8. Procurement
- 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]
Project Plan for Implementation of Veeva QMS at IRWD v1.0 Page 24
10. Integrated Change Control
Implementation of Veeva QMS at Ironwood Pharmaceuticals Essay
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0-45%
37-1 points
The background and/or significance are missing. No search history information is provided.
75-1 points
Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration.
48-1 points
There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met
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