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PROJECT CHARTER EXAMPLE

Project Name: LMT/PEL LIMS Deployment Project Prepared by John Doe and Mary Smith Date: 8/22/06

INITIATION:

LABORATORY INFORMATION MANAGEMENT SYSTEMS (LIMS) DEPLOYMENT

February 6, 2006 (Supersedes the December 15, 2005 general LIMS Deployment Charter) Operating Group Task #95: Provide Plan for LIMS

deployment at Facility A and funding plan.

Project Manager: John Doe, CIO

Project Administrator: Mary Smith, Project Management Office

SYNOPSIS: Laboratory Information Management Systems (LIMS) are information management systems designed to track, organize, store and report on laboratory-generate data and analytical results. In addition, when used in core laboratories, the LIMS provides a portal for generating accounting reports and the systematic distribution of resulting data back to the requesting scientists and collaborators. LIMS can operate in both highly regulated and non -

regulated environments. LIMS can meet all Good Laboratory Practice (GLP) requirements by providing full sample tracking, user certification, instrument and calibration management, standards & reagents management, full auditing, CFR21 Part 11, report and sample scheduling, bar coding, on-line help, and other functions. By eliminating several common sources of human error and by connecting directly to the laboratory-based instrumentation, LIMS improve laboratory efficiency. A full-featured LIMS will manage various laboratory data types including sample log-in, reporting analytical results, billing, and other related operations.

PURPOSE/ BUSINESS NEED:

As a result of the increased use of various high throughput technologies in virtually all areas of biological research, sophisticated software is needed to help research and diagnostic laboratories manage, analyze, and organize complex data. In addition, core technology facilities must be able to manage and distribute the data back to collaborating scientists in a

controlled and secure manner. They must also have billing, tracking, and other capabilities to perform administrative functions efficiently. A well-designed LIMS can provide the solution to all of these production requirements.

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SCOPE AND ACCEPTANCE:

LMT The scope of the LMT component of the project includes a tested, documented, and functional LIMS no longer dependent on the Finch system. Enhancements will be developed separately and not be included in this project. Once the basic functionality has been documented and approved by the LMT, its users, the Customer, the Informatics Group, and the Project Manager, changes will not be made to the scope without the written approval of the LMT head and the Informatics Group Project Manager.

PEL An initial needs assessment of the PEL lab and user-base will establish the basic functionality of the LIMS for this project. Enhancements will be developed separately and not be included in this project. Once the basic functionality has been documented and approved by the PEL, its users, the Customer, the Informatics Group, and the Project Manager, changes will not be made to the scope without the written approval of the PEL head and the Informatics Group Project Manager.

APPROACH: Standard development process utilized in the LIMS project: 1) Informatics Group LIMS developer will collect user requirements and document it as requirement description for user review.

2) Informatics Group LIMS developer will write the corresponding use cases to cover requirements. 3) Informatics Group LIMS developer will have system architecture design for user review. 4) Informatics Group LIMS developer will write detailed design document for major components/classes. 5) During the software development phase, unit testing, regression testing and system integration testing are required.

6) During the software quality assurance phase, QA testing and user acceptance testing will be required. 7) Final user acceptance testing will be given prior to the final production release.

PRODUCT DESCRIPTION AND DELIVERABLES:

The LIMs to be deployed in the support laboratories will provide various functions for the designated recipient laboratories. Additionally, the LIMs described in this document will be deployed in various stages that each will represent a milestone. The Project Management Plan includes a Work Breakdown Structure and timeline for the achievement of those milestones (each with significant improvements and/or additional capabilities). This approach is designed to provide an immediate benefit to the recipient laboratories and

demonstrate robust core functionalities which will then be extended in the subsequent versions of the software.

LMT LIMS

Phase I: Data Analysis

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Phase II: Barcode Inventory Tracking System

Phase III: Reporting System

Phase IV: System Consolidation

PEL LIMS

Phase I: Needs Analysis

Phase II: Prototype System Development, Review, and Validate

Phase III: Implementation and testing

Phase IV: System Consolidation, Documentation, Training; Production Release

PROJECT MANAGEMENT:

Project Management processes according to the standards and methodology set forth in the

Project Management Institutes' Body of Knowledge will be used to manage the deployment of the LIMS project. The Project Management Plan (PMP) will include the following elements:

Project Charter

Description of the Project Management (PM) approach

Scope statement

Work Breakdown Structure

Cost estimates, start and finish dates, roles and responsibilities

Performance measurements baselines for scope, schedule, and cost

Major milestones and target dates for each

Resources, effort, and related costs

Risk Management Plan

Quality Management Plan

Communications Management Plan

The project management plan is a living document that will be updated by the Project Manager and Project Management Administrator as required. The plan will be executed and

overall project performance evaluated on a regular basis to provide confidence that quality standards are being met in each laboratory module of the LIMS. The project team will be developed to maximize skills and competencies to enhance project performance. Information will be disseminated to project stakeholders on a schedule outlined in the Communications Plan.

ASSUMPTIONS, CONSTRAINTS, RISKS:

High level project risks and constraints include, but are not limited to

● Funding availability—To date 78% of the total dollars for LIMS development at the Facility has been supported by Company A, Inc. Maintenance, updates, refinements, and continued deployment of the LIMS now necessitate support through the Customer’s contract. While there is agreement on the basic

necessity for continued deployment of LIMS, funding for this and future LIMS development has currently not been identified.

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● Availability of Skilled Resources—The proposed human resource requirements for the LMT-PEL LIMS development, caBIG compliance modification, and ongoing systems maintenance includes a LIMS Integrator, LIMS Programmer, and LIMS HelpDesk support. These are the minimal resource requirements to support the scope of this project within the schedule identified in the PMP.

● Laboratory Commitments—Accurate identification of LIMS requirements, interpretation, testing, and design depend on the patience and commitment of the laboratory in focus.

● Current industry standards for LIMS—caBIG compliance standards are subject to change; new LIMS standards may evolve.

● Laboratory Requirement Changes—Congressional appropriations can affect the mission, scope, and management of Government laboratories at any time, thus also affecting LIMS requirements at any time during the development process.

A detailed Risk Assessment is included in the PMP.

RESOURCES:

Project Resources:

Human Resources:

1 Project Manager (project duration)—plan, manage, control project (25%)

1 Project Administrator (project duration)—facilitate project planning, execution,

and communication (30%)

1 (+) IT Developer per laboratory—design and develop LIMS according to individual lab

specifications (100%)

1 IT Developer—assist in design and development (100%)

1 IT Support staff (ongoing)—support installed LIMS product (training, helpdesk, system maintenance) (100%)

Material and Services Resources:

Equipment: Hardware, Software

Financial Resources:

Labor: $******** Equipment: Hardware, Software: $3,000 Travel: $10,000 (LIMS Meetings)

COMMUNICA-TION AND REPORTING:

Communication will follow the Communications Plan outlined in the PMP. Stakeholders include Customer Management, Company A, Inc., Management, the LIMS Deployment Project Team, LMT & PEL laboratory staff, and LMT & PEL users.

Status reports will be submitted to Customer Management through the OG representative monthly.

Company A, Inc., Management will be updated weekly for the Customer/Contractor

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meeting.

Communications among the Project Team members will be weekly initially, and as needed as the project progresses.

LMT & PEL laboratory staff will be apprised as participants in the process.

LMT & PEL users will be apprised informally throughout the process by the respective LMT & PEL program spokespersons for their projects.

The Project Manager will be the communication focal point with the Group A until the transition of the LMT LIMS is complete to Group B.

CHANGE MANAGEMENT:

All change requests will be documented, submitted to, and assessed by the Project Manager (PM) and Team Lead for impact and project necessity prior to PM approval. If change is approved, the project schedule, scope, and budget will be updated accordingly

and communicated to appropriate stakeholders in accordance with the Communications Plan. The PM/project team will communicate the approved change and updated schedule to the staff responsible for implementing the change.

PROJECT TEAM:

PROJECT TEAM ROLES AND RESPONSIBILITIES

John Doe: Project Manager (PM)—Preparing project plan; monitoring and controlling project; approving project changes; quality assurance

Michael Doe: Project Team Lead—Supervising technical staff assigned to project; monitoring/approving project change requests; informing the PM on all issues impacting the project and project plan.

Sue Jones: Project Team member—Liaison with Group A and communicating quality issues as required

Jane Smith: Project Team member—LIMS liaison between LMT and LMT users and the Project Team; communicate status of LMT LIMS progress and problem resolution;

reporting quality status for LMT LIMS John Smythe: Project Team member—Performs needs analysis for LMT and PEL LIMS

requirements; contributes to establishing quality performance objectives Jerry Schultz: LIMS Integrator and Project Team member—Software developer responsible

for fulfillment of the project's technical requirements in accordance with the Project Quality Assurance Plan

Mary Smith: Project Team member—Project Management administration; assurance that appropriate project management processes are observed throughout the project, including Quality Assurance reporting standards in accordance with the Communications Plan.

Customer and Contractor Managements' Project Team participation is important to provide clarification and guidance on any and all matters affecting the project team's ability to execute the project successfully.

APPROVAL(S): Project Manager: Date: Sponsor: Date: