DocuWare Case Studies Prescription for Safety: Profusio Leipzig's Implementation of DocuWare

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	Prescription for Safety: Profusio Leipzig's Implementation of DocuWare DocuWare

Prescription for Safety: Profusio Leipzig's Implementation of DocuWare

DocuWare

Technology Category	Application Infrastructure & Middleware - Data Exchange & Integration
Applicable Industries	Healthcare & Hospitals Pharmaceuticals
Applicable Functions	Quality Assurance
Use Cases	Regulatory Compliance Monitoring
Services	System Integration
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - Data Exchange & Integration

Applicable Industries

Healthcare & Hospitals

Pharmaceuticals

Applicable Functions

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Services

System Integration

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.

About 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.

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.

Impact #1	The implementation of DocuWare has made the execution of processes significantly more simple and faster.
Impact #2	There is no need for a paper archive in the future and the employees appreciate saving time during storage and retrieval.
Impact #3	The Quality Assurance department especially likes the sorting capabilities by various criteria.

Impact #1

The implementation of DocuWare has made the execution of processes significantly more simple and faster.

Impact #2

There is no need for a paper archive in the future and the employees appreciate saving time during storage and retrieval.

Impact #3

The Quality Assurance department especially likes the sorting capabilities by various criteria.

Benefit #1	More than 450,000 pages of production, quality control, and release documents are archived every year, adding 1,500 every day.

Benefit #1

More than 450,000 pages of production, quality control, and release documents are archived every year, adding 1,500 every day.

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Overview

Prescription for Safety: Profusio Leipzig's Implementation of DocuWare

Operational Impact

Quantitative Benefit