An established global specialty pharmaceuticals company located in Switzerland wanted to set up a and automated data exchange with their main three logistics service providers. This data exchange was required to digitise and automate all communication concerning the transactions of remotely located inventory and thereby reducing time-intensive manual transactions that are prone to error.
ESCIMCO was tasked with project managing the business side for setting up of this automated data exchange covering Electronic Records and Electronic Signatures (21 CFR Part 11).
ESCIMCO identified five relevant processes with the Key Users and created process maps covering all inputs, actions, decisions and outputs of the processes.
The technical specifications of the automated data exchange were drawn up to cover all the project deliverables and the requirements for the automated data exchange.
Using the process maps ESCIMCO created comprehensive test scripts that would test all defined functionality. Additionally, with support of the Key Users, ESCIMCO identified relevant test scenarios to be tested in the test phase using the testscripts.
The process maps also served as the basis for the training documentation and standard operating procedures, that were used during the go-live phase.
For all five processes the automated data exchange between the global specialty pharmaceuticals company and the three LSP’s successfully went live to the full satisfaction of the customer, ahead of plan and within budget.