I recently had the opportunity to project manage the implementation of a new change management module, which was part of a QMS upgrade for one of our biopharma clients.  We wisely moved away from customization, but systems are so configurable these days, clients can’t review every option to determine their best course. The key is to let business process requirements drive the decisions.

To accomplish this, the real work lies in gaining a deep understanding of the business process you are trying to automate.  While one could get a good picture of what this might be like through interviewing the process owner(s), unless you “get in the game”, you will have only scratched the surface.  Getting on the same page as the client with regards to the details of the business process will surely put you and ultimately them in a good position for a successful implementation.

Software vendors can typically pick up a good understanding of their customer’s business processes in the onsite sessions which are then presented in the requirements specification.  While this is helpful, I submit that a few days onsite is generally not sufficient to capture all the nuances within complex biopharma business processes.   It is rare, especially in a process that crosses multiple areas of expertise, that one or two people can effectively and accurately represent the needs of the players outside of their department.

Having an effective project manager onsite to bridge the gap between business process and the software solution helps, but it is imperative that he/she engages all players in the design effort, particularly in the conference room pilot leading up to the User Acceptance Testing.   The project manager must be immersed in the full manual process, by walking through it with all players in the various departments and learning the value of every step in each phase of the workflow.

Intimately knowing the business process, and the various players in it, will give you a solid foundation from which you can effectively represent your clients’ needs and will lead you to a successful implementation of the solution.