etmf-vendorsAll too often we hear horror stories about eTMF implementations that did not deliver appropriate value because either the solution was inadequate or because the implementation project was not successfully managed. Based upon Paragon Solutions' experience helping clients select products as well as serving as the implementation partner for several successful implementations, we believe there are three main things you can do to help ensure that the project is more successful:

Make sure that your team is ready for the project.

Being part of an eTMF implementation project is rarely the full-time job of your employees or colleagues. As such, you need to do up-front work to make sure that they can support both the project and their regular responsibilities. You can achieve this by defining the team structure and outlining the responsibilities per project role.

  • Workstream Leads vs. Core Team vs. Sponsors.
  • Expectations for team members around the estimated time allocation per project.          

As part of project initiation make sure that you work with the supervisors of team members to outline this commitment to the managers as well

Establish clear expectations of what the eTMF solution will provide.

Having unclear or incorrect expectations for the system is one of the most frustrating components of struggling eTMF implementations. Make sure that you - and your stakeholders - have a solid understanding of what you need the system to do and make sure that you share this with the vendor early on in the project.

  • Define/map the processes that you wish the tool to support. This will support the definition or requirements, serve as supporting documentation, an serve as an input to change management/training activities.
  • Spend time on user requirements. Too many times we have seen user requirements sent out in RFPs that do not adequately allow companies to narrow down the field of potential vendors due to vague/generic requirements. Leverage the process maps and internal, and external, expertise to craft specific and detailed user requirements
  • Invest the time to clearly understand the content structure/information architecture that you will be adopting as part of the eTMF implementation. All the top vendors will support the TMF Reference Model, but you will probably want to modify the model for your specific needs - only 25 percent of companies adopt the model as-is per the TMF Ref Model 2014 survey.

Make sure that the vendor is aware of what you expect them to do!

Contracts serve as the agreement around what the vendor is to provide, but too often they are being negotiated by outsourcing and procurement folks who are not as intimately familiar with eTMF projects as your team and the vendor implementation team. This can result in a situation where there is uncertainty around expectations and can lead to unnecessary disagreements between client and vendor.

The best way to do this is to have thorough pre-contract discussions with the vendor - and implementation partner - to finalize roles and responsibilities and to define expectations around deliverables.

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