Pharmaceutical leader boosts efficiency and enables long-term growth with standardized global processes from ºÃÉ«ÏÈÉúTV Documentum for Life Sciences
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.
We see ºÃÉ«ÏÈÉúTV Documentum for Life Sciences solutions as a key enabler of the transformation initiative at Fresenius Kabi.
To break down data silos and streamline its core processes, Fresenius Kabi deployed ºÃÉ«ÏÈÉúTV? Documentum? for Life Sciences solutions with ºÃÉ«ÏÈÉúTV? Life Sciences Smart View¡ªoffering global employees rapid, secure access to key information.
Unify processes and seamlessly share information across the extended Life Sciences enterprise
Control critical quality documentation, streamline and automate processes with compliance
Create, review and approve submission documentation faster
Deliver secure, compliant, cloud-based access to content and processes
Get a trusted partner to guide your Information Management path
Many teams across Fresenius Kabi had already been using ºÃÉ«ÏÈÉúTV? Documentum to drive their day-to-day work for several years. Based on its positive experiences with the ºÃÉ«ÏÈÉúTV solution, the company¡¯s IT team selected Documentum for Quality and Manufacturing and Documentum for Research and Development¡ªpart of the Documentum for Life Sciences solution suite. The solutions are the foundation for the company¡¯s new global platform to manage regulated content.
¡°ºÃÉ«ÏÈÉúTV Documentum for Life Sciences met all our key requirements,¡± commented Hofmeyer. ¡°One of the big advantages is that the ºÃÉ«ÏÈÉúTV solutions allow us to take a platform approach¡ªsupporting 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 ºÃÉ«ÏÈÉúTV D2 Configuration application is particularly useful, as it makes it easy to build custom workflows in ºÃÉ«ÏÈÉúTV 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.¡±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.¡±
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 ºÃÉ«ÏÈÉúTV environment within just six weeks, allowing them to take advantage of the new capabilities rapidly.
¡°The ºÃÉ«ÏÈÉúTV 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 ºÃÉ«ÏÈÉúTV solutions once, and employees start using the new documents or process automatically.
Thousands of users across more than 40 countries rely on ºÃÉ«ÏÈÉúTV solutions to drive their day-to-day work¡ªeliminating information silos, reducing costs and mitigating compliance risk while helping the company accelerate its ¡°Vision 2026¡± transformation.
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 ºÃÉ«ÏÈÉúTV 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 ºÃÉ«ÏÈÉúTV 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.¡±
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 ºÃÉ«ÏÈÉúTV 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¡ªeverything is right at their fingertips.¡±As its global deployment continues, Fresenius Kabi ultimately aims to unite all its business units on a single, central document management platform.
¡°We see ºÃÉ«ÏÈÉúTV 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.¡±