PHOENIX Group
PHOENIX Group Transforms Quality Management with M-Files by Achieving Compliance, Efficiency, and Cost Savings Across 29 Countries
Highlights
- Improved Efficiency and Compliance: Ensured compliance with pharmaceutical guidelines, reducing manual effort, and enhancing audit readiness.
- Harmonization Across Affiliates: Consistency in quality processes across PHOENIX's affiliates while allowing local adaptations.
- Scalability and Flexibility: A scaled EQMS implementation based on the needs and resources of each affiliate.
- Cost Savings: Significantly reduced costs with consolidated document management systems across the organization.
Use Case
Change Management
Compliance Management
Process Management
Quality Management
Records Management
Risk Management
Training Management
Industry
Pharmaceutical and Life Sciences
Medical and Health
Country
International
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Company Introduction
PHOENIX Group, one of Europe’s leading healthcare providers, plays a critical role in the pharmaceutical supply chain, connecting the industry with hospitals, pharmacies, doctors, and patients across 29 countries. With over 48,000 employees and more than 200 logistic sites, the company operates in a highly regulated environment, governed by pharmaceutical guidelines such as Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP). To ensure compliance and streamlined processes, PHOENIX transitioned from paper-based systems to a centralized and harmonized Electronic Quality Management System (EQMS) powered by M-Files.
Key Challenges Before M-Files
With a highly regulated industry, PHOENIX is subject to stringent pharmaceutical guidelines, including Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP), to ensure compliance across its entire supply chain.
Before implementing M-Files, many of the company's locations were using paper-based systems for quality management, non-conformance handling, and change management. This created inefficiencies and high operational costs, as managing compliance in a paper-based environment required significant effort. During inspections and audits, PHOENIX was informed by audit authorities and other competent bodies that the current practices no longer align with modern standards or represent the state of the art.
The executive board mandated a comprehensive study to identify and evaluate existing document management systems (DMS) within the organization to reduce costs. “The original starting point was the order of the executive board to make a DMS study, where we had to analyze and evaluate the different existing document management systems within our group and to define one application which is the most appropriate one to save money in the end", said Dr. Ingo Florian, Head of Corporate Quality Management at PHOENIX Group.
"We have made the decision to go with M-Files, and we still hold on to this decision. The success in the countries in the end gave us feedback that it was the right decision."
Dr. Ingo Florian, Head of Corporate Quality Management, PHOENIX Group
"We created a standard vault, which offers all 4 applications: DMS, non-conformance and CAPA (Corrective and Preventive Actions), change management, and audit management. Of course, the countries and affiliates are allowed to configure things they need, not only the language, but also other details, but the foundation is almost the same."
Dr. Ingo Florian, Head of Corporate Quality Management, PHOENIX Group
The M-Files Solution
After a thorough evaluation process, M-Files was selected as the most appropriate system for PHOENIX Group. Ingo stated, “M-Files turned out to be the most appropriate one for us with regards to functionality, validity, costs, and benefits.”
Efficiency with an M-Files Pilot and a Standardized Vault
The system was initially implemented in pilot countries, and based on the learnings from those implementations, PHOENIX developed a standard vault that would act as a blueprint for future rollouts across other countries and affiliates. This standardized approach ensured harmonization across the company while allowing for local customizations based on specific requirements. “We created a standard vault, which offers all 4 applications: DMS, non-conformance and CAPA (Corrective and Preventive Actions), change management, and audit management. Of course, the countries and affiliates are allowed to configure things they need, not only the language, but also other details, but the foundation is almost the same”, Ingo said.
The standard vault, configured with workflows and metadata fields, allowed affiliates to implement M-Files more efficiently with a more consolidated and harmonized system within the PHOENIX group. As an additional service Corporate QM has validated the standard vault regarding the defined workflow and main functionalities which drastically reduces local validation effort.
The Results
Streamlined Audits and Compliance
The transition from paper-based to electronic systems had a transformative impact on PHOENIX’s operations. Not only did it lead to significant cost savings, but it also streamlined processes, ensuring uniformity and compliance across all affiliates.
Ingo shared that the shift to an electronic system made inspections and audits much easier: “In the end, it is now much easier during inspections and audits to show the auditors: look we have an electronic system, we are able to search via metadata fields according to processes, teams, to topics and so on.” Moreover, the system has significantly reduced the effort required for training compliance. “We also have compliance with regards to training, because M-Files has an end-to-end relationship, which means we are able to show this SOP was distributed to these employees and on the other hand, this employee received this SOP and completed the training.”
PHOENIX has found that the move to M-Files also fostered harmonization across its various sites, which was essential for a company that continues to grow through mergers and acquisitions. “When you compare the SOP of Sweden with Slovakia, with Romania, you say, why do you call it PHOENIX Group? I don’t see any matching documents,” said Ingo. The introduction of standardized templates and workflows ensured a more uniform look and feel for all affiliates.
Lastly, M-Files has allowed for scalability within the organization, enabling smaller affiliates with fewer resources to implement the system in phases, starting with document management and expanding to non-conformance, change management, and audit management over time.
"We also have compliance with regards to training, because M-Files has an end-to-end relationship, which means we are able to show this SOP was distributed to these employees and on the other hand, this employee received this SOP and completed the training."
Dr. Ingo Florian, Head of Corporate Quality Management, PHOENIX Group
Enhanced Efficiency and Self-Sufficiency with M-Files Managed Services
In addition to M-Files helping PHOENIX digitalize their systems and streamline collaboration across different countries, the company has also been leveraging M-Files Managed Services for several years. These services have been crucial for managing, developing, and maintaining a regulated Quality Management System across multiple international business divisions.
The key benefits of M-Files Managed Services for PHOENIX include supporting and empowering their internal IT support team. This has led to a better understanding of M-Files, resulting in fewer incidents and change requests, and making their support team more self-sufficient. Furthermore, the Managed Services team has worked closely with the PHOENIX IT team to standardize the M-Files solution across their business divisions, leading to more efficient implementations as PHOENIX continues to expand the use of M-Files throughout their organization.
Future Plans
PHOENIX Group is currently in the process of rolling out M-Files across its remaining countries and affiliates. The organization plans to complete the rollout within the next 2-3 years, with an average implementation time of 4-6 months per country. Additionally, as the system is continuously improved based on feedback from each rollout, the standard vault becomes more mature, ensuring that the organization stays at the forefront of compliance and operational efficiency.
“We hope that in 2-3 years we are almost ready with implementation of all countries. The standard vault becomes more and more mature. it is an iterative system, which is from my perspective, a very successful one.”
“We have made the decision to go with M-Files, and we still hold on to this decision. The success in the countries in the end gave us feedback that it was the right decision,” concluded Ingo.
Conclusion
By choosing M-Files as its standardized electronic Quality Management System, PHOENIX Group has been able to achieve significant cost savings, significantly improve its quality management processes, improve efficiency, harmonize its operations across multiple countries, and enhance its compliance capabilities across its highly regulated operations.
The scalable, flexible, and lean solution has not only simplified document management but also laid the foundation for future digital transformation.
Why M-Files?
M-Files is the leading platform for knowledge work automation. With the M-Files platform, knowledge workers can find information faster, work smarter, and achieve more. M-Files features an innovative metadata-driven architecture, embedded workflow engine, and advanced artificial intelligence. This enables customers to eliminate information chaos, improve process efficiency, and automate security and compliance.
