Implementing an eTMF solution within 9 months

A leading European bio pharmaceutical company headquartered in Switzerland working with Fabry diseases and insomnia needed to implement an eTMF solution in 9 months.

The client wanted to spin out it’s drug discovery operations into a new company in a strict timeline. This included a transition of a number of studies and associated documents to a new integrated eTMF solution fully applying to DIA reference model 3.0, with no or limited time to fail.

With help from HERAX the client managed to select a vendor using HERAX vendor selection methodology which includes user requirement specification, capability demonstrations and negotiations to achieve best outcome from the selection.

After the vendor had been selected the chosen eTMF software was implemented with HERAX Pharma specific project management approach employing Agile methodology in collaboration with the vendor.

During the implementation change management were applied to ensure best adaptation to the new tool, processes and understanding of benefits for each role (i.e. “What’s in it for me?”). New processes were developed to standardize across systems and harmonize the interdisciplinary business processes from clinical to IT. Standard operating procedures, work instructions and templates were updated/delivered to reflect the new system landscape.


  • Workshops were a collaborative iterative process occurring in parallel with business process design work stream
  • Initial configurations were presented for feedback
  • Configuration changes were reviewed live in the system, enabling the end-users to see the impact of decisions
  • Fit-for-purpose applied before final testing and go-live

Realized benefits
The client managed transition within the given timeframe enabling efficient data capture, standardized compliance and inspection readiness from day one

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