Pharmigon's Implementation of DocuWare for GMP-Compliant Quality Management
Region
- Europe
Country
- Germany
Product
- DocuWare
Tech Stack
- Digital Document Management
- Barcode Scanning
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Digital Expertise
- Productivity Improvements
Technology Category
- Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries
- Healthcare & Hospitals
Applicable Functions
- Discrete Manufacturing
- Quality Assurance
Use Cases
- Inventory Management
Services
- System Integration
About The Customer
Pharmigon is a healthcare company based in Germany that specializes in manufacturing patient-specific and highly specialized preparations, primarily for the targeted treatment of tumors. The company's production takes place in state-of-the-art clean room laboratories, which are equipped with precise computer-assisted monitoring in accordance with Good Manufacturing Practice (GMP). This requires strict document processing and archiving, which are key elements for GMP-compliant quality management. The company has been relying on digital document management for many years and has integrated it into their existing pharmacy management system.
The Challenge
Pharmigon, a manufacturer of patient-specific and highly specialized preparations for the targeted treatment of tumors, operates in state-of-the-art clean room laboratories. The company is required to adhere to Good Manufacturing Practice (GMP), which necessitates meticulous document processing and archiving. All documentation, including work instructions, forms, and plans, must be version-controlled and subject to a defined life cycle. Additionally, records must be created, archived for a specified period, and protected against tampering or manipulation. The company had been relying on digital document management for several years, but needed a solution that could seamlessly integrate with their existing pharmacy management system.
The Solution
Pharmigon chose DocuWare for its high level of functionality, intuitive use, and seamless integration into their existing pharmacy management system. This integration allows for the automatic transfer of production documents, patient data, or commercial records from the industry solution to the central document pool. Pharmigon employees also have three powerful document scanners at their disposal for digitizing paper documents. Indexing and filing are carried out via barcodes applied to each order. DocuWare adopts these details as index terms and uses them as central parameters for the subsequent workflow to verify correct manufacturing. An initial check is performed by the production manager, a second by the quality control department. If the quality control department also confirms the correctness of the manufactured substance with an electronic stamp, a final release is made by a responsible employee.
Operational Impact
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