To achieve their goals, MorphoSys needed to make their quality and vendor oversight processes lean to scale and expand with the company.
Epista and MorphoSys built Veeva processes aligned to meet the conditions for each business area, while also allowing flexibility where needed.
MorphoSys is a virtual company dedicated to discovering, developing, and delivering therapies for people living with cancer and autoimmune diseases. They help drive innovations that improve health care around the world. To achieve their ambitious business goals, MorphoSys needed to make their quality and vendor oversight processes leaner and more standardized to scale and easily expand as the company grows.
MorphoSys had four business critical processes they wanted to incorporate into their existing Veeva Vault QMS: deviations, change control, complaints, and OOX. However, the individual business areas each had their own way of executing these processes, accommodating for specifics of commercial products, Investigational Medicinal Products, as well as their internal procedures. At first, it seems as though these processes might be too unique to harmonize. Yet, to scale and grow, MorphoSys needed to overcome this challenge.
MorphoSys asked Epista for help. The Epista team included quality experts in both business practices and technical system setups. The project started with a thorough review of MorphoSys’s current ways of working in order to define the critical success factors for their new digital practices. And over the next two months, Epista facilitated several “Phase 0” workshops to define in detail how to best align the processes from MorphoSys’s different business areas and how to match them with the generic processes in Veeva. The goal was to keep all processes as close as possible to industry best-practice and Veeva’s standard processes to minimize maintenance efforts, while still adding enough customization to fully support all of MorphoSys’s daily operations.
In the end, the team managed to build one, aligned Veeva process for each of the following: deviations, change control, complaints, and OOX. These backbone processes meet the harmonized conditions of all the different business areas while still allowing for minimal specifications for each of their unique requirements.
This process optimization process paid off. When Veeva started their configuration workshops with MorphoSys, they already had the backbone processes configured. This head start allowed MorphoSys to focus on other details during the implementation phase, ensuring they get the maximum benefit from their Veeva platform.
“We were impressed with how Epista was deeply knowledgeable about our processes. This is the kind of dedication we highly appreciate. With no doubt, it was one of the contributing factors to how smoothly the Veeva QMS Phase 0 went. Epista's experience, both with Veeva eQMS and QA processes, helped us see our processes from another perspective and supported our decision-making.”
- Reshma Rao, Senior Manager Quality Assurance GMP; Alice Hoffmann, Director/Deputy Head of Quality Control; and Anaissa Ali, Senior CMC Quality Manager
Get in touch to optimize your processes for maximum business benefit.
*Footnote: After May 26, 2024, medical devices registered under MDD will have to re-register under MDR.
We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.