This leading clinical-stage biotechnology company is on a mission to improve lives through the curative potential of gene therapy. However, in order to continue on their path of growth and expansion, the company knew its tech stack had to not only be top of the line, but able to support their accelerating plans toward building a manufacturing facility. After previously completing the first phase of migration with their EPM dataset to Oracle, the company again looked to Apps Associates to guide the next phase of their future-proofing project—migrating the ERP side of business to Oracle.
Prior to the migration, the company’s ERP data needed consolidation for visualizing inventory across multiple GMP organizations for tracking and planning—an outcome their homegrown solution made from Microsoft Excel and individual partner’s inventory management systems could not achieve. Rather, the company needed stronger, more structured planning and inventory management that also included automation capabilities. Further, to keep the company’s tech stack streamlined with one source of truth across EPM and ERP—which would create a solid foundation for their future manufacturing facility—Oracle provided the best advanced capabilities and offerings that their manual system simply outgrew.
As the company’s partner for phase one (EPM), Apps Associates returned to support the second phase ERP migration, helping to maintain the same level of best practice and integrity across the breadth of the full implementation. Already familiar with the company’s needs in terms of scaling ability and goals to build out their manufacturing business, Apps was the clear choice to ensure that Oracle was fully implemented prior to the go-live date of the new facility.
Before diving into development, the company wanted to ensure everything was understood and the foundation for their future expansion was sound, which is why phase two faced no time constraint. Rather, both the internal company team and Apps’ team of experts took a slow and steady approach—with Apps experts, “…taking the time to sit through sessions ahead of the migration in order to learn about our specific business needs as they related to the biotech industry and the company’s place within it,” shared their Sr. Director of Supply Chain. In addition, the company ran the Apps team through building processes ahead of the migration, to ensure the configuration of Oracle also matched the needs of working within GMP manufacturing guidelines.
“Apps always remained positive despite us learning the system while building processes at the same time. Their experts understood that it was better to pause and take the time to understand it and get it done right and per GMP and quality compliance, versus just getting it done for the sake of meeting a deadline. Apps never put pressure on our team and through that approach, we’re set up and equipped to work smarter and better for years to come in Oracle,” said the Sr. Director of Supply Chain.
Once aligned on key business and industry requirements, Apps broke out the second phase of the ERP migration into two distinct stages. The first included migration of data from numerous streams to support CMO manufacturing, including:
The second focused on Process Manufacturing to support onsite manufacturing.
To tackle the migration, Apps leveraged a combined team of 10 internal employees from varying departments within the company, as well as 10 subject matter experts and an Apps project manager—guiding the internal team throughout the entire migration, including the development of inventory management, supply planning, and contract management procedures prior to implementing Oracle.
Apps led the build out leveraging Oracle Test Scripts as the framework for GMP procedures, and the entire process included 25 SOPs, with Apps Associates creating work instructions to support this phase of the migration. With these scripts in place, the company’s team will be able to create a similar number of SOPs for the final phase of the migration, which would tackle Process Manufacturing, in support of the company’s planned onsite manufacturing capabilities.
During the implementation itself, Apps experts assisted and provided guidance on the data configuration for uploading all the current Product Information for Oracle. This process included the migration of both raw materials and the company’s GMP products. To further ensure the new system ran correctly and would continue to do so following completion of the project, the Apps team established protocols for data validation, which were also in accordance with GMP regulations. With the protocols in place and able to confirm the data, the company was officially fully migrated to and running on Oracle.
With their EPM and ERP data systems successfully migrated to Oracle, the company finally has one source of truth across the entire organization. Consolidation, specifically for inventory and manufacturing schedules, will help the company to not only gain better insight into their current standing but also allow them to maximize their inventory as they scale.
The company also realized the benefit of having Apps expertise lead the large-scale, complicated migration process—which was key to its overall success in terms of project completion and future-proofing the business.
Following the completion and success of the migration, the company continues to partner with Apps in a managed services capacity, ensuring their new Oracle system is functioning correctly at all times.