Project Deliverables: Enterprise Systems
Over the last two plus decades of managing enterprise system selections and implementations for biotech, pharma, medical device, and diagnostic companies (collectively known as life sciences), I’ve developed quite the portfolio of documentation deliverables. While I am a PMI (Project Management Institute) certified PMP (Project Management Professional), the day-to-day demands for project management are more nuanced than what is included in the PMBOK (Project Management Body of Knowledge).
I’ve refined my processes and deliverables over the last 25 years, mostly for controlled system selections and implementations (subject to Sarbanes-Oxley or GxP / 21 CFR Part 11). I don’t believe in hoarding information and decided to share not only my list of deliverables, but what’s included in these deliverables.
I tailored the deliverables to my client’s specific needs depending on the system complexities, the size of the team, regulatory requirements, and my client demands. The deliverables for a configurable, off-the-shelf (COTS) system are (in mostly chronological order):
— Project management document or project document (project guidebook)
— Detailed project plan (I use MS Project)
— Validation plan and final report(for projects that require validation per 21 CFR part 11)
— Data migration plan, data migration documentation support, summary of data migration
— Testing plan, testing documentation, summary of testing
— Functional requirements document (FRS)
— Configuration / specification document(s)
— Standard operating procedures (SOPs) and user guides
— End user training material and summary of training
Note: for a selection project, the deliverables will be slightly different, and for a validated system implementation, there are more deliverables that are defined within the Validation Plan. This list does not include the detailed statements of work for external vendor resources. Bottom line: there is no one-size-fits all approach.
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!
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.
