LIMS Project Success Through Proper Project Governance and Communication - Pittcon 2017 Tech Talk

Premier Laboratory Informatics ExpertsStrategic Planning Implementation Validation

LIMS Project Success ThroughProper Project Governance and

CommunicationsHoward J. Rosenberg, Ph.D.Principal Industry Consultant

© 2017 CSols, Inc.

Agenda

What is project governance? Why do I need project governance? Simple project governance structure Roles and responsibilities LIMS team roles Communications plan Summary Questions

© 2017 CSols, Inc.

What is Project Governance?

LIMS Project Governance is the framework for Planning Executing Completing a large LIMS project

The focus of Project Governance is Key decisions that shape the project Key decisions that drive the project direction

Project Governance has three core components

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LIMS Project Governance Framework

The decision making structure

The roles & responsibilities of the people within the structure

The information that informs them• Budget/Costs• Regulatory• IT

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Why do I need Project Governance?

Because: The organization structure is designed for business as

usual decision making – not for projects

Projects have stakeholders scattered across the organization and they need to be brought together for fast and efficient decision making

“Why can’t I run my project using the organization structure?”

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Simple LIMS Governance StructureExecutive

Sponsor(s)

Steering Committee

Program Manager

LIMS Project Manager(s)

LIMS TeamLevel

Freq

uenc

y of

Mee

tings

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Roles & Responsibilities

Executive Sponsor(s) Key R&R: Direction & Oversight One or more needed “Owns” the major business segment If multiple Executive Sponsors

One must be designated as the Senior Executive Sponsor – Final decision maker

Others serve on Steering Committee

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Roles & Responsibilities

Steering Committee Key R&R: Directing & Advising One representative per segment involved

IT, Business, Quality, Etc. This is the forum for

Raising issues & concerns Making adjustments

» Direction» Resources» Timing

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Consensus Model Executive Sponsors

Consultative Model Executives & Senior Managers

Understand issues and needed changes Provide advice and assessment of impact Make adjustments w/I their areas

Advisory Model Major Business Segments Representatives

Monitor program progress Understand issues and adjustments made Assess impact w/I their business segment Communicate decisions to their business segment

Steering Committee Models

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Roles & Responsibilities

Program Manager Key R&R: Management & Integration

Program Manager Project Manager Program = multiple projects

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Program Manager vs. Project Manager

Program Manager Integrates efforts Assesses and refines

approaches and plans Ensures good

communication across projects

Implementation arm of the program sponsor(s) and / or steering committee

Project Manager Plans, organizes, directs,

and controls the project effort.

Manages communications within the project

Manages for on-time delivery of specific products.

Manages work within the project plan framework.

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LIMS Team Roles

LIMS Project Manager LIMS Business Analyst(s) LIMS Implementer(s) / Programmer(s) IT Technologist(s) LIMS Trainer(s) Change Management Facilitator Cross section of the LIMS project stakeholders

Scientists, Technicians, IT, Management, QA, Others LIMS System Administrator (future) LIMS Super-User(s) LIMS Validation Manager (if regulated) LIMS Validation Experts (if regulated)

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Sources of LIMS Team Members

Your Company/Organization The Vendor 3rd Party Consultants

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Communications Plan Sets up approved methods of

communication Establishes standard

communication procedure

Frequency and type of updates provided to the stakeholders

Provides consistency in information flow Removes misinterpretations and doubts What information to be sent to whom & when Helps keep everyone on the same page

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Communication Plan

Communication Items include: LIMS project timeline and status updates LIMS project budget / performance vs. budget Key deliverables

Needs Requirements Workflows Etc.

Training plans and updates Prospective lab downtimes Post Go-Live support plans

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What does successful PG look like?

Rapid/timely decision making Everyone will be on the same page Hit time-lines, budget Go-live/deployment will be on schedule No surprises

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Howard J. Rosenberg, Ph. DPrincipal Industry Consultant

www.csolsinc.com