Project Document: Enterprise Systems
The success of complex enterprise system projects depend on planning and structure. They also depend on good communication, strong leadership, organizational commitment, and a solid guide.
Over the past 25 years of selecting and implementing enterprise systems for life sciences companies, I’ve relied on the Project Management Document or Project Document to collect all of the project details into one place and clearly communicate to all of the stakeholders.
Who creates: Project Manager with input from, and in collaboration with, multiple internal and external resources
Who approves: the team including Executive Sponsor, Business Sponsor, and the external team members
When: after project planning, after signing any vendor agreements, prior to the actual project kick off
What’s Included:
— Background including a summary of the project, history, and guiding principles
— Project scope including project objectives, implementation objectives, acceptance criteria / success factors, assumptions, business processes and system functionality, data migration, interfaces / integrations, reporting / analytics
— Project management approach including phases, project team members, responsibilities, activities, deliverables, timeline, project ground rules, communication management, issue tracking, project change control, documentation management, training, and testing
— Risks and risk mitigation strategies
— Other project requirements including procedures, training, disaster recovery, business continuity
— Project change control
Note: if the system will be validated in accordance with 21 CFR Part 11, there will be a validation section that points to the Validation Plan.
How long is this document? Once again it depends on the complexity of the project. Mine are typically between 10–30 pages.
Why Share This Now? Back when I was an accountant, working for my dad’s accounting firm, we had a lot of small businesses as clients. The owners of the small businesses struggled with basic bookkeeping and accounting which meant that we couldn’t add value to them and their businesses because we were so focused on the fundamentals. We created a few accounting classes for them in the form of Accounting 101, 102, 201, and 202 so we could do more with them.
I’m applying the same principles here. If I can help my clients (prospective or current) help themselves with projects and project deliverables, then I get to elevate my role beyond the day-to-day and into a strategic and advisory role which, frankly, is a lot more fun!
Check out my blog post Project Deliverables: Enterprise Systems for the complete list of deliverables with links other blog posts.
Have Questions or Require Assistance?
Feel free to reach out to Terri with any questions you might have via email at terri.mead@solutions2projects.com or through the company website SolutionsProjects, LLC.
About the Author
Terri Hanson Mead, MBA, PMP, is a technology and compliance strategist for biotech, pharma, medical device, diagnostic, and digital health companies. Through her company, Solutions2Projects, she helps life sciences companies align technology roadmaps with corporate objectives and meet IT compliance requirements in a complex and regulated industry. As an expert witness, Terri provides pre-litigation consulting and expert witness services for failed technology projects, including enterprise systems.
