• John D. Hannan

Identifying Business Requirements for a Life Sciences ERP Implementation

Updated: May 25

One of the most important pieces of selecting and implementing an ERP system at a life sciences company is the identification of the business requirements. These requirements play a part in many facets of the process

  • They drive the evaluation of the software and software vendor's capabilities

  • They define scope that will be used to estimate the cost, timeline, and staffing levels of the implementation

  • Testing scripts, including those used in FDA Validation scenarios for both the Operational Qualification (OQ) and Performance Qualification (PQ), are written to validate that business requirements are met as intended

  • Training guides are often based on the test scripts, which are based on business requirements

Having worked with dozens of Pharmaceutical, Medical Device, and Contract Research Organizations (CROs), I prefer to take a different approach than asking clients to start from scratch with a blank slate and draft requirements. I interview stakeholders to understand the objectives of the business and understand their needs.

From there, I present a set of requirements I have created based on my experience with companies, like them, and challenge the business to determine that these requirements will work for them. There will be an amount of needs specific to any company, where adjustments to the standard life sciences requirements are made and the business requirements are finalized. Requirements are grouped by area (functional or technical), for example:

  • Technical Specifications (including SaaS, user load capabilities, mobility)

  • Finance (GL, AP, AR, Budgeting, Fixed Assets)

  • Procurement

  • Sales & Marketing

  • Inventory

  • Warehousing

  • Manufacturing

  • Quality

  • Workflows

  • Reporting & Business Intelligence (BI)

Business owners for each area should sign-off on the final set of requirements as to ensure acceptance and buy-in. They should also be communicated beyond the written form to validate understanding. This is most effectively done through in-person reviews utilizing visuals to diagram such elements as approval workflows and business processes.


John Hannan LLC is making ERP visions a reality. If you're looking for expertise to implement a new system, upgrade to a new version or integrate other add-on solutions, contact us today and learn how we're helping similar organizations.

In a related blog, The Software Selection Process for a Life Sciences ERP Implementation, I discuss the software selection process and what to expect for activities and timelines.




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