Project Charter - Template given

This document refers to the project "<Implementing Veeva QMS at Ironwood Pharmaceuticals >", which is implemented by the organization "<Ironwood Pharmaceuticals".

The Project Charter formulates the practical requirements and documents the high-level description of the product, service or other deliverable that should meet these requirements and will be result of the project.

The Project Charter is issued and signed by the Initiator or Sponsor of the project and formally legitimized the existence of the project. It provides the Project Manager with the authority to use the organizational assets in the project operations.

The approved Project Charter formally initiates the project.

If the project consists of several phases, the Charter can be updated to verify or improve the decisions taken during the previous iteration of the Project Charter development. In such a case the Charter is re-issued and signed as amended.

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

· Manage Audits by allowing auditors to download and review Audit responses and help complete signatures via web.

· Manage any change within the company using change controls and eliminate paper performed procedure and wet-signatures.

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.

The implementation of Veeva QMS must fulfill the following requirements:

· All agreed project documentation has been delivered and approved.

· Super User Training has been successfully completed

· Setup

· Define users and parameters.

· Define roles and company structure details.

· Manage and populate users and roles information.

· Setup System Configuration parameters.

· Define Document Types and Attributes

· Configure PDF Rendering Settings

· Define Document Workflow Templates

· Document

· Create official/controlled documents through a formal revision and approval process.

· Archive controlled documents and retrieve them as needed.

· Formally request changes to controlled documents through an official revision and approval process.

· Modify controlled documents through a formally established electronic procedure.

· Publish official/controlled documents.

· Easily retrieve archived controlled documents.

· Provide access to the last approved and official version of a controlled document.

· Attach electronic signatures to controlled documents of those participating in the revision/approval chain.

· Training

· Prepare training curriculums, each one including several training activities.

· Assign and track training activities for different resources.

· Define and maintain training requirements per job function.

· Create and record training activities related to controlled documents.

· Apps: Document Control (Standard with installation)

· Request the creation or modification of a document.

· Assign responsibilities and deadlines.

· Approve requests electronically.

· Track status of a request electronically.

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

*Note – All deliverable dates are currently adjusted to the month available and refer Project Plan for more accurate details on date availability for individual document.

Project acceptance will be performed by Ironwood's designated employees, through the approval of the

project's deliverables listed in Section 10 of this document.

Final project acceptance will be performed through the approval of the Project Closure (PC-SOL-001) by the Project Sponsor, Project Owner and the Project Manager at Ironwood.

The criteria for deliverable's evaluation and approval will be:

· Compliance with contract between Veeva and Ironwood.

· Compliance with the Project Purpose defined in this document (Section 3).

· Fulfillment of project requirements defined in Section 6 of this document.

· Compliance with 21 CFR Part 11 FDA regulations.

· Achievement of the specified results for all test/validation activities.

· Conformity with Veeva Quality Standards and Ironwood Computer System Validation SOPs

Syed Rahim will be acting as a Project Manager from Ironwood Side and is responsible for following;

· Monitor and review the project's health at regular Steering Committee meetings

· Keep the project scope under control as emergent issues force changes to be considered

· Reconcile differences in opinion and approach, and resolve disputes arising from them

· Provide those directly involved in the project with guidance on project business issues, especially issues which would compromise the success of the project

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Signed/Project sponsor(s) or charter approving authority

N/A