In Mfg & R&D there are a number of critical machines. Initially under the terms of the TSA, whilst we owned these devices, Lilly wanted us to wipe them completely before they could be used on the new Elanco network. This was not an ideal situation because these validated machines are critical to the business, and if we had to unplug and wipe each device individually, this could have led to business disruption. The wipe process also promised to be lengthy and expensive. There were two scenarios causing concern:
- GxP workstations like instrument controllers in labs and on the manufacturing floor. These exist across every single R&D and Manufacturing site
- GxP servers at a plant site which are considered critical
Our colleagues at Fort Dodge Manufacturing IT team have lived through a number of these different transition projects and based on their knowledge of Elanco infrastructure they were able to document a proposed process - a cleanse of a GxP server, rather than a wipe. WWT, ETS, and M&Q IT worked together to develop a script that can be executed to cleanse a GxP workstation. Lilly has in principle agreed to a cleanse process for the above 2 categories of critical devices. We still need to provide Lilly with some evidence that it could work which will be taken through their Risk Acceptance process, but we are in a much better position than we were originally.
Whilst GxP migrations will happen later in the overall migration timelines, this is a huge step forward for the program, and one which was causing us a few sleepless nights!