Prescription for Safety: Profusio Leipzig's Implementation of DocuWare
Customer Company Size
SME
Region
- Europe
Country
- Germany
Product
- DocuWare
- Steribase
Tech Stack
- Windows 2008 Server
- VPN
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Productivity Improvements
- Cost Savings
Technology Category
- Application Infrastructure & Middleware - Data Exchange & Integration
Applicable Industries
- Pharmaceuticals
- Healthcare & Hospitals
Applicable Functions
- Quality Assurance
Use Cases
- Regulatory Compliance Monitoring
Services
- System Integration
About The Customer
Profusio Leipzig Gesundheits GmbH is a pharmaceutical manufacturer based in Leipzig, Germany. The company is a contractor for pharmacies and is specialized in producing patient-specific intravenous drips. Top product quality and on-time delivery are the main success factors of the company, which was founded under the name Oncosachs Pharma in 2006 and belongs among the market leaders in Germany. Pharmaceutical production is bound by very strict laws in Germany. Safety and control of the production process need to be guaranteed and documented. Therefore, pharmaceutical companies are required to create comprehensive documentation and protocols regarding the production process and must retain them for at least 5 years after the expiration period of the drug has ended.
The Challenge
Profusio Leipzig, a pharmaceutical manufacturer, is required to create comprehensive documentation and protocols regarding the production process and must retain them for at least 5 years after the expiration period of the drug has ended. This results in more than 450,000 pages of production, quality control, and release documents that have to be archived every year, adding 1,500 every day. The company needed a solution to better cope with this document volume and to be able to quickly find documents on demand. The company also wanted to save natural resources by completely going paperless. The documentation security was the key aspect in drug manufacturing.
The Solution
The DocuWare document management system was implemented in February of 2010. The system was installed on the existing Windows 2008 Server and on all client workstations which are part of the production process. The integration with Steribase, the pharmaceutical production software used by Profusio, was performed by an Authorized DocuWare Partner and was then approved by the state testing authority based in Dresden. This ensures that the documentation of the production, testing, and release processes with DocuWare follows the rules of the GMP standard. An integrated document workflow also controls all steps in a fully automated way – from production to the release of the drugs. As additional hardware, a Kodak I1220 was purchased for capturing of paper documents.
Operational Impact
Quantitative Benefit
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