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j-kronberger
Discoverer
In this blog, I would like to give you an insight into how you, as a responsible person for compliance in a life sciences company, can deal with the increasing requirements of UDI compliance and how a proposed solution looks like.

UDI compliance is an ongoing task


Life Sciences companies are facing multiple challenges when it comes to regulations.

A primary challenge here is scaling up to meet new and yet unknown requirements. Another very important aspect is the time to compliance.

Cloud solutions help keep the pace in this fast moving world. But Life Sciences companies must still respect compliance boundaries like GxP-compliant operations of the different cloud solutions. This implies rethinking the way of working and setting up a cloud governance framework.


Especially within MedTech companies, UDI (Unique Device Identification) compliance takes a huge part of the daily business. UDI is already a mandatory requirement in different markets and we see that more and more unknown or at least not finalized UDI requirements in markets like Europe, Saudi Arabia, Brazil and many more are about to follow. It is unclear what future UDI requirements from other authorities might look like and how companies can implement them in the short term and keep them under control in the long term.

Therefore, MedTech companies need to find a way to handle the unknown, which means:

  • Plan resources for moving UDI related targets

  • Plan against non-finalized external deadlines


Using a dedicated cloud solution here can definitely do the trick.

Understand UDI compliance as an opportunity


Although the various UDI regulations are a challenge, they can also be seen as an opportunity for MedTech companies:

  • Although UDI is an obligation, it makes sense to see UDI more as an enabler of opportunity rather than a regulatory duty.

  • UDI can help in standardizations. For example, UDI can be the basis to create a common vocabulary for the whole supply chain of MedTech companies.

  • Think UDI holistically by defining a global company-wide long-term strategy for UDI supported by a software solution that has a clear extensibility concept to manage UDI in future.

  • Rethink current business processes and use automations wherever it is possible.


UDI Compliance can be Managed and Scaled


As UDI already is and will stay an ongoing challenge, it is advisable to look at UDI not only for each market separately, but to think UDI company-centric. Using automations for processes boosts data quality and shortens the time to compliance at once. Combined with the re-use of data whenever it is possible UDI can be managed much more efficiently.

Regarding the scaling up of UDI, it is really helpful to use the power of the mass. That means, benefit from co-innovations with the right partner and other MedTech companies for required features. UDI shouldn’t be seen as a competitive topic - collaboration really can make the difference by selecting the best way to ensure UDI compliance worldwide.

MedTech companies should choose experienced partners who have met global UDI challenges before and have proven processes, software, and people to help them drive a successful project.

Benefit of experienced partners


SAP and we from p36 are working together in SAP’s Life Sciences Industry Cloud to bring the solution to MedTech companies. The customers benefit from the experience, know-how and the environment that enables them to successfully manage and scale their business in order to meet UDI compliance requirements.

SAP, who knows business processes by heart and p36, who offers the full managed service around UDI can support MedTech companies to think UDI from a new perspective and to setup their business processes for the long-term.

Summary


Hopefully this article has shown you how powerful a partnership with experienced partners can be and how such collaborations can help life sciences customers deal with an issue that is seemingly difficult to navigate and manage in a compliant manner.
To learn more about the collaboration between SAP and p36, click here to watch our webcast.

Now, it's your turn. Share your thoughts on UDI with us. What are your challenges in your company? How do you handle UDI compliance within your medical device company?
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