Calliditas: Managed Operations for Dynamics 365

Continuously improving and always compliant ERP systems


After delaying several in-scope tasks until after go-live, Calliditas needed a trusted partner to help keep their new ERP system in a validated state.


Now, through changes and forced updates, Epista’s Managed Operations team ensures their ERP system is continuously improving and always compliant.

Calliditas is a biopharmaceutical company focused on renal and hepatic diseases. They help drive innovations that improve healthcare around the world. After implementing their Dynamics 365 ERP system, Calliditas needed a Managed Operations partner to skillfully handle any compliance challenges that arise – from change management to forced system releases to testing and revalidation of processes, and more.

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During Calliditas’ large ERP implementation project, they delayed several in-scope tasks until after the system went live. They were unsure how to keep their system in a validated state throughout the coming change process. And, to make matters more complex, Dynamics 365 forces at least four system updates per year. Calliditas knew they needed a trusted partner to help them stay in control.


Over the years, through implementation of several systems, Epista and Calliditas have built a long-lasting relationship. In fact, Epista was the validation partner during the D365 implementation. So, to meet the challenges of operating their ERP system, Calliditas called Epista.

Now, through business changes and forced updates, Epista’s Managed Operations team ensures Calliditas’ ERP system is continuously improving and always compliant. Specifically, this includes:

  • Impact assessments
  • Test and validation activities
  • Change process management to keep validation documentation in control
  • Update of documentation and work instructions
  • Compliance management – deviations, periodic reviews, and other compliance-related tasks
  • And more…

For Calliditas, a robust partner means more than someone who can accurately complete the required activities. They use Epista as a sounding board. When they have questions about validation and ERP requirements, we share our knowledge as a trusted partner on their ERP journey.

Epista’s team gives Calliditas assurance that there is always someone to provide support, to share knowledge, and to guide them through their journey to be continuously improving and always compliant.

Karin Norén, IT Governance Manager at Calliditas, is very pleased with their engagement with Epista. “Our collaboration with Epista’s ERP Managed Operation service is professional. They deliver very high-quality service and documentation - always on time.”

Get in touch if you want to stay ahead of potential issues while optimizing value during the operation of your ERP system.

*Footnote: After May 26, 2024, medical devices registered under MDD will have to re-register under MDR. 

Talk to an expert

Anders Kimfalk
Director Operations - Lund

Services we provided for this project

We are dedicated to continuously improving compliance and business. And by turning compliance obstacles into business opportunities, we believe that we can help your Life Science company achieve its goals - quickly and efficiently.

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