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Fresenius Kabi logoFresenius Kabi

Pharmaceutical leader boosts efficiency and enables long-term growth with standardized global processes from OpenText Documentum for Life Sciences

Fresenius Kabi logo

About Fresenius Kabi

Headquartered in Bad Homburg, Germany, Fresenius Kabi AG is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, clinical nutrition and biosimilars.

Healtcare professional speaking with patient in healthcare facility
  • Sales:
    €7.8 billion in 2022
  • Size:
    42,000 employees
  • Presence:
    70 locations worldwide

Summary

Challenges

  • Aimed to drive growth while keeping costs under tight control.
  • Manually managing regulated content reduced operational efficiency.
  • Information silos increased regulatory risk.

Solution

  • Replaced multiple siloed systems with a unified document management platform.
  • Enabled document management on mobile devices.
  • Rolled out the document management platform to global employees.

Results

  • Enabled cost-effective scaling as the business grows
  • Streamlined regulatory compliance processes
  • United global teams on a single platform

Challenges

  • Rapid business growth led to a proliferation of siloed document management systems
  • Information silos increased compliance risk and the time and resources required to complete audits
  • Manual document management processes reduced operational efficiency

With operations worldwide, Fresenius Kabi AG develops a wide range of pharmaceuticals. With a focus on autoimmune diseases and cancer treatment, the company strives to equip healthcare professionals around the world with lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.

Fresenius Kabi is growing rapidly, both organically and through acquisition. In recent years, the company incorporated Merck KGaA’s biosimilars business into its portfolio, accelerating the pace of its expansion.

Andreas Hofmeyer, product owner of regulatory and quality IT systems at Fresenius Kabi, explained, “To prepare for the decade ahead, Fresenius Kabi has embarked on a transformation initiative, named ‘Vision 2026.’ Driving continued growth and enhancing competitiveness are two of the key pillars of the corporate strategy. And in IT, we looked for ways to help the business achieve these goals.”

The IT team at Fresenius Kabi identified a valuable opportunity to empower global research and development (R&D) and quality and manufacturing (Q&M) teams to work more efficiently. In the past, all the different business units and teams relied on their own individual systems and processes to create, store and manage mission-critical documentation. The company aimed to improve productivity and reduce costs by offering a standardized, automated approach to document management.

Neha Chandel, project delivery manager at Fresenius Kabi, said, “We operate in a highly regulated sector. All employees must follow standard operating procedures [SOPs], and many business processes require managers to review and approve documents.

“In the past, these activities involved circulating documents via email for review and then printing them off, signing them and scanning them back into the document management system. As well as taking up a great deal of valuable work hours, this approach made audits time-consuming and labor intensive. It also increased our exposure to regulatory risk.”

In the past, Fresenius Kabi used document management systems from multiple different vendors to manage regulated content. To realize its transformation goals, the company decided to build a central document management platform that could support thousands of R&D and Q&M employees across its global business.

Medical technician in lab holding beaker

We see OpenText Documentum for Life Sciences solutions as a key enabler of the transformation initiative at Fresenius Kabi.

Andreas Hofmeyer
Product Owner, Regulatory and Quality IT Systems, Fresenius Kabi

Solution

To break down data silos and streamline its core processes, Fresenius Kabi deployed OpenText™ Documentum™ for Life Sciences solutions with OpenText™ Life Sciences Smart View—offering global employees rapid, secure access to key information.

Products deployed

Services provided

Building on a proven solution

Many teams across Fresenius Kabi had already been using OpenText™ Documentum to drive their day-to-day work for several years. Based on its positive experiences with the OpenText solution, the company’s IT team selected Documentum for Quality and Manufacturing and Documentum for Research and Development—part of the Documentum for Life Sciences solution suite. The solutions are the foundation for the company’s new global platform to manage regulated content.

“OpenText Documentum for Life Sciences met all our key requirements,” commented Hofmeyer. “One of the big advantages is that the OpenText solutions allow us to take a platform approach—supporting many different R&D and Q&M workflows on a shared enterprise information architecture. The solutions also address essential regulatory compliance requirements, with capabilities such as controlled printing and a full audit trail of every user action.”

Chandel added, “The OpenText D2 Configuration application is particularly useful, as it makes it easy to build custom workflows in OpenText Documentum to address country-specific legal and business requirements across our global user base. For example, we can offer a custom document review process for our teams in Germany, while other countries share a standard workflow.”

Enabling on-demand information access

Using Life Sciences Smart View, Fresenius Kabi can offer its users secure document access and management capabilities on mobile devices for the first time. As a result, Q&M employees working in the company’s production sites no longer need to rely on a workstation and connect to a VPN to consult SOPs or work instructions, and managers can review and approve documents on the move using smartphones and tablets while the system captures comments and approval data within the audit trial.

Hofmeyer commented, “Being able to review documentation using an iPhone is a big efficiency boost, especially for our many production sites. Employees can get the information they need on demand, without interrupting what they are doing to go and find a workstation.”

Beginning a worldwide rollout

Over the last two years, Fresenius Kabi has begun replacing its legacy and acquired document management systems with the new, central document management platform. On average, the company’s IT team can bring new global teams into the OpenText environment within just six weeks, allowing them to take advantage of the new capabilities rapidly.

“The OpenText solutions are very easy to use, which means most teams can import their existing documents into the platform with minimal support from IT,” said Hofmeyer. “Since we first started rolling out the solutions, there’s been a great deal of interest from Fresenius Kabi teams around the world. We’re currently migrating employees from our U.S. business to the new platform, and we anticipate that our user community will continue to grow steadily in the years ahead.”

When a regulatory requirement or our internal process changes, we can update the relevant documentation and workflows in the OpenText solutions once, and employees start using the new documents or process automatically.

Neha Chandel
Project Delivery Manager, Fresenius Kabi

Results

Thousands of users across more than 40 countries rely on OpenText solutions to drive their day-to-day work—eliminating information silos, reducing costs and mitigating compliance risk while helping the company accelerate its “Vision 2026” transformation.

Enabled cost-effective scaling as the business grows

As its global deployment continues, Fresenius Kabi is strengthening its ability to manage regulated content. When the company’s U.S. business is onboarded to the platform, the user community for document management will almost double, and the company is confident that the OpenText solutions will remain easy to manage and maintain.

Chandel explained, “One of the big benefits of shaping standardized global workflows is that we can support a large number of users without sending the cost and complexity of IT soaring. For example, when a regulatory requirement or our internal process changes, we can update the relevant documentation and workflows in the OpenText solutions once, and employees will start using the new documents or process automatically.”

Hofmeyer added, “Over the last two years, we have been able to decommission several legacy document management systems, reducing our operational costs significantly.”

Streamlined regulatory compliance processes

Since it first adopted Documentum for Life Sciences solutions, Fresenius Kabi has boosted the efficiency of core activities such as regulatory compliance.

Hofmeyer said, “Today, it’s much easier for our R&D teams to collaborate on the same documents in parallel, which in turn helps them to ensure that they can send their submissions to our regulators in a timely manner and cut time to market for new products.”

Fresenius Kabi can implement fine-grained document access controls in Documentum, helping to ensure that information can only be accessed by authorized personnel and printed on specified devices.

Chandel commented, “Every user action in OpenText Documentum creates an audit trail, which makes external audits a much less time-consuming process. When an auditor asks a question about the provenance of a document or the history of an approval, employees don’t need to trawl through their email inboxes—everything is right at their fingertips.”

United global teams on a single platform

As its global deployment continues, Fresenius Kabi ultimately aims to unite all its business units on a single, central document management platform.

“We see OpenText Documentum for Life Sciences solutions as a key enabler of the transformation initiative at Fresenius Kabi,” concluded Hofmeyer. “By empowering our teams to complete essential document-related processes in a controlled, efficient and secure way, we’re supporting the business on its way to healthy long-term growth.”

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