An operational LIMS in R&D : Challenge accepted
One of the 5 largest international pharmaceutical groups
Our client, an international pharmaceutical group, asked SPC to improve the version of its LIMS solution, used since 2008 and supporting the R&D activities (Clinical Development) in Europe and the USA.
There are many challenges to this project such as Increasing access and use of the existing system by optimizing both the user interface and follow-up of analysis requests, increasing the number of present users by deploying new modules supporting processes not presently covered, further standardizing the application where possible by returning to the original functions brought by the new version of the LIMS solution.
All the Project Management services from piloting the project to validation and training were given to SPC thus requiring a team of 8 SPC consultants.
600 application users on the same day
The system must allow 600 people to use it on the same day with all the operational and previous audit data. Special attention was therefore given to the data migration activities including those of stability studies, change management and Go-Live plan which are shared with all the administrators on the 6 sites chosen in France, Germany and the USA.
As the application will release the clinical batches, the migration must be accompanied by a formal validation approach piloted by our teams and based on work and functional risk analyses and the migration of prerequisite data.
As is often the case, we had also to work with the limited availability of business resources.
« Lean management » to streamline, and prototypes to convince
We used a « Lean » approach for this migration project which was initiated by a process analysis phase and a business case. Due to the complexity of the project, we recommended both dividing the project into parts and a « gap analysis » (specification-oriented workshops) during which we particularly discussed maintaining a specific solution compared to the return to a standard solution.
As the availability of business resources was limited, we provided a project team consisting almost exclusively of senior consultants who have perfect knowledge of the context, supported business processes and existing application functions.
Due to the multilingual nature of the project and the imposed organizational constraints, the hard choice only to involve a team of « Key Users » in France in the specification workshops was suggested by our project leader. The local administrators were however involved in the validation of the specification documents and the presentation of the prototypes.
Finally, to limit the translation workload, our team in charge of training recommended and put together specific training material. The training plan, support and training sessions on site in French and in English were mainly led by our teams.
A better application and a 60% increase in the number of licenses
The system was launched for all users simultaneously including an immediate reconnection of the interfaces notably with the MES (Manufacturing Execution System) application on about 10 data exchange flows thus starting the « Hypercare » phase and the formal supervision of the system. In this project, there was also the approval of more than 400 documents including 60 training supports and more than 150 training sessions in France, Germany and the USA.
Today, the new modules are being used and the number of user licenses has increased to more than 60% which therefore shows the increase in use of the newly-delivered LIMS application.