Oncopeptides needed a new eDMS that met their criteria and could manage the influx of new employees - all while under time and resource constraints.
Epista helped Oncopeptides successfully get to market fast while establishing processes for the long term with Veeva QualityDocs.
Oncopeptides, a small Swedish biotech company, is on a journey from an R&D outfit to a full-blown pharma production company. This includes replacing their previous paper-based document management system with an electronic one (eDMS).
Most Life Science professionals believe that getting a new document management system up-and-running is a huge project and a big headache. Catarina Lundhagen Stensils, QA and Process Coordinator from Oncopeptides proves that it doesn’t have to be that way. Catarina shares how the team found and implemented the right document management solution for their goals, all while under serious time and resource constraints.
First, Oncopeptides laid out critical 'must haves':
Oncopeptides needed to be able to manage an increase in employees, which would make a process flow with circulated printed copies quite unmanageable. Catarina says: "We intend the system to be a long-term solution for the company, so that's why decided to go for a software as a service." After determining their needs, the Quality Assurance (QA) team landed on Veeva QaulityDocs. Catarina notes that they did not base their decision on price, as Veeva is not the lowest priced system. Instead, they focused on the system that best matched Oncopeptides' strategy.
And they succeeded with an aggressive timeline for their Veeva implementation. One key factor that made the process run quickly and smoothly was that the QA team had a clear goal: to select and implement a scalable EDMS system to replace their existing SharePoint archive for governance and procedure documents.
In order to have a smooth implementation process, you must fully understand why you're doing the project in the first place. If everyone in the organization is on the same page in regard to what needs to happen, there will be fewer hiccups when implementation begins.
According to Catarina, they couldn't have done it without their internal QA team, which only consisted of two people when they started the project. They worked together to make decisions quickly, and this sped up the process. Catarina also says that their lack of pre-conceived expectations also helped make them successful, as being too detail-oriented can make it easy to get stuck on small details that will only slow the project down.
Catarina knew that a strong implementation partner was a key to success. Oncopeptides needed a team who knew the software and had the experience to smooth over potential bumps in the implementation. With Epista on their side, Oncopeptides got extensive knowledge of the Veeva platform and experience to overcome any challenges that arose, such as filling a knowledge gap.
Lastly, Catarina sites the full support that her team received from their top management. The organizational leaders gave Catarina and her team very little restriction and full reign to do what was necessary. This, in combination with constant encouragement, allowed the project to reach its full potential.
We selected Epista as our implementation partner because they know Veeva and had the experience and knowledge to support us in our time-pressed situation, with all the challenges that included. - Catarina Lundhagen Stensils
"You can achieve ambitious goals when you put your mind to it. You just have to go for it." says Catarina. In this case, Oncopeptides wanted a new EDMS system. Veeva QualityDocs said that the implementation would take eight weeks. Oncopeptides did it in six. How did they achieve that successful result, with very few resources? In addition to recommending using an implementation partner, Catarina reflects on a few lessons learned during the project.
Inform them about the change with as much detail as possible, so that they can be prepared for what is to come. This is important because project of this size will increase the entire organization's workload for some time - even after completion.
You can never over communicate the extent to which you expect your organization to be involved with the project. It's also important to make sure that you inform them of the benefits and remind them why this project is necessary for the business.
Ensure that when the project phase has ended, the people that need to use the platform will confidently be able to do so.
When it comes to project of this scale, it is important that everyone knows what is happening and why it's happening, along with the benefits that it will provide the organization. In addition to communication, it's imperative that the end users are trained. Oncopeptides used the Veeva trainer, classroom trainings, Microsoft Teams training, and created PowerPoint slide decks for self-training. Yet, Catarina says it was not enough. “People tend to forget,” she says. So, even if you think you’ve done enough, it never hurts to provide extra training for your employees.
The project phase is long over for Oncopeptides, but that doesn't mean there aren't anymore challenges. "The operational phase is where the real work starts", says Catarina. There are constant optimizations and improvements, such as improved templates.
Looking ahead: Oncopeptides is currently still working with Epista after go-live, for managed operations.
Every business system need improvements and optimizations to ensure that it continues to meet the needs of the business. And Oncopeptide's QualityDocs system is no exception. Catarina let us in on how they identify these optimizations at Oncopeptides. First, she says, they have internal QA meetings to discuss potential improvements. This is then followed by monthly cross-functional process alignment meetings. So, why two sets of meetings? If Oncopeptides truly wants Veeva to work optimally for them, it's imperative to actively engage the entire business to ensure that everyone's needs are met.
Oncopeptides decided that they needed to switch from their existing paper-based document management system to an electronic document management system. They needed a system that was fast to implement and would grow with them.
Currently, Oncopeptides has expanded their use of Veeva Quality Suite to include even more modules, such as Training and QMS. Besides the Quality Suite, several commercial modules and Veeva Safety is also in use. As the company grows, so does their Veeva system! Catarina says that, with Veeva QualityDocs and the help of Epista, Oncopeptides definitely got what they were looking for: a system that could support their journey from an R&D outfit to a full-blown pharma production company, and beyond.
*Footnote: After May 26, 2024, medical devices registered under MDD will have to re-register under MDR.
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