In the previous blog, UCB’s strategic approach how to achieve complete visibility in the pharmaceutical supply chain and to comply with serialized track and trace regulatory requirements was outlined.
In this blog, Stéphane Aubert, Director IT – SAP Logistics Execution and Program Manager Serialization Track&Trace – IT with UCB, shares five principles which were followed to successfully run the implementation project.
1. Anchor the business value firmly
Defining the business value was vital to get business buy-in, as well as to keep on track with the right focus. In this case, the key value was easy to determine: compliance. Non-compliance would lead to the inability to distribute our products on various markets, meaning numerous patients not receiving their treatments, so the investment was clearly justified.
2. Determine requirements early on
When the project started in 2012, regulatory requirements for serialized pharmaceutical products were not clearly defined. UCB needed to base the project on assumptions. The first key decision was to keep technical requirements as simple as possible to be able to adapt when regulatory requirements would become clearer. Further, the advantages of corporate standardization had to be balanced with the requirements of the local specificities. Consequently, a top-down and a bottom-up approach had to be combined. To minimize cost and complexity, the SAP standard was applied where possible and a pilot was also implemented to confirm the selected design before rolling-out solution to production environment.
3. Cooperate with stakeholders and use staff project carefully
The high level of dependencies across business domains, locations and suppliers required strong integration to ensure alignment and accountabilities. Legal and process requirements had to be checked on global and local levels, joint validation of key rules were agreed on early, and close collaboration helped promote acceptance.
The project was staffed with executives, talented employees from UCB and top consultants from implementation partners, e.g. Accenture and Advanco. In addition, strategic resources were allocated to build the final solution, coordinate the parties, and manage the transition to support organizations.
4. Ensure timely delivery, effective tracking and proper risk management
The program was complex. The solution involved new technology and high level of interdependencies. This meant UCB had to be prepared to deal with unforeseen issues. To ensure on time delivery, a close pulse was taken on the development progress and testing. Corrective measures were taken on a weekly basis, especially on prioritization and parallel phase execution to ensure maximum adherence to plans.
In order to anticipate issues, the team built a tool that mapped processes, scenarios, developments and tests scenarios. This gave visibility of interdependent components that enabled the team to quickly identify how an issue in one area cascaded into others and thus better assess the true impact.
Risk management was run carefully, as UCB was dealing with a validated environment with GxP relevant components and as the project touched upon core business processes, i.e. production, warehousing and distribution. A centralized issue and risk management log was used as of day 1 and placed in the central collaboration site for continuous project control.
5. Manage change and achieve operational readiness
Lastly, before going live, change management and training played a key role. Expectations were managed proactively, organizational and cultural changes prepared in detail, and strategies had to be in place to overcome possible resistance.
Disciplined project management was worth the effort. UCB achieved readiness to existing serialization and track & trace regulations, prepared for upcoming ones, and improved performance and quality of the manufacturing processes.
Stéphane Aubert Susan Rafizadeh
Director IT – SAP Logistics Execution Life Sciences
Program Manager Serialization Track&Trace - IT SAP