DocuWare Case Studies Pharmigon's Implementation of DocuWare for GMP-Compliant Quality Management

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	Pharmigon's Implementation of DocuWare for GMP-Compliant Quality Management DocuWare

Pharmigon's Implementation of DocuWare for GMP-Compliant Quality Management

DocuWare

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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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.

About 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.

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.

Impact #1	The implementation of DocuWare has allowed Pharmigon to ensure the safety of the manufactured preparation. The system's seamless integration with the existing pharmacy management system has streamlined the process of transferring production documents, patient data, and commercial records to the central document pool.
Impact #2	The use of barcodes for indexing and filing has improved the efficiency and accuracy of document management. This has also facilitated the verification of correct manufacturing through a workflow that involves checks by the production manager and the quality control department.
Impact #3	The company is continuously identifying new areas to use digital document management, such as in the area of mobility. They aim to define workflows to enable stamp-controlled approval processes to be carried out at any time and from any location via mobile devices.

Impact #1

The implementation of DocuWare has allowed Pharmigon to ensure the safety of the manufactured preparation. The system's seamless integration with the existing pharmacy management system has streamlined the process of transferring production documents, patient data, and commercial records to the central document pool.

Impact #2

The use of barcodes for indexing and filing has improved the efficiency and accuracy of document management. This has also facilitated the verification of correct manufacturing through a workflow that involves checks by the production manager and the quality control department.

Impact #3

The company is continuously identifying new areas to use digital document management, such as in the area of mobility. They aim to define workflows to enable stamp-controlled approval processes to be carried out at any time and from any location via mobile devices.

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Overview

Pharmigon's Implementation of DocuWare for GMP-Compliant Quality Management

Operational Impact