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DocuWare 5.1c Meets Guidelines of U.S. Food and Drug Administration (FDA), Compliance Renewed

18 Aug, 2011

DocuWare 5.1c Meets Guidelines of U.S. Food and Drug Administration (FDA), Compliance Renewed


Newburgh NY – August 16, 2011 – DocuWare, document management specialists, announces their latest version of DocuWare 5 continues its legacy of compliance with US Food and Drug Administration guidelines. The status was confirmed by an audit conducted according to regulations set forth by the FDA. This means that the integrated document management program may be used by companies closely regulated by the FDA in the pharmaceutical and food processing industries.

The Food and Drug Administration (FDA) regulates the manufacturing, storing and sale of products in the pharmaceutical and food processing industries to protect American consumers. Audits are regularly performed on companies working in these fields as well as any of their vendors/suppliers, and all are required to conduct strict tests accompanied by detailed documentation. This also includes any foreign companies supplying the U.S. market. Even IT systems used in this area must meet FDA regulations.

DocuWare 5.1c was submitted under the FDA’s Title 21 Code of Federal Regulations (CFR) Part 11 for the Pharmaceutical and Food Processing Industries. This CFR outlines the requirements that software – and the processes they control – must meet. DocuWare has held this certification since it was first audited at the end of 2006. This year’s audit was again conducted by META Solutions Inc., an independent consulting company specialized in the pharmaceutical and food processing industries. At DocuWare’s German headquarters, all of the company’s internal processes regarding software development, service and quality control in addition to the program’s functionality were closely scrutinized.

As was the case the first time, the program’s high level of security and support of all types of electronic signatures impressed the consultants. Further advantages noted include DocuWare’s tamper-free archiving, its consistent documentation of processes and comprehensive training program for employees and partners.
The results of the current audit are available under "Regulatory Compliance Statement, June 16, 2011" at www.docuware.com/fda.

Internationally-operating pharmaceutical and food processing companies who are looking to automate and improve workflows for the long-term with document management can use these guidelines for their own use with DocuWare.

DocuWare – Integrated Document Management Solutions
DocuWare is an integrated document management software solution that easily automates business processes by electronically managing and sharing documents. Regardless of format or source, documents are stored in one central document pool. One search quickly locates all documents related to a business transaction. All access is secure, controlled, and logged.

With Web-based document management, automated workflow and powerful integration tools to both hardware and software, DocuWare’s flexibility enables complete mobility, transparency and scalability to grow with the customers’ needs. A standard feature is an embedded and fully licensed powerful SQL database enabling full text retrieval. DocuWare also supports all forms of electronic signatures and is independently certified to ensure compliance with important government and private sector standards.  DocuWare solutions are known for their easy installation, administration and operation, as well as an exceptionally low Total Cost of Ownership. There are over 10,000 installations, with more than 100,000 daily users; in over 70 countries (available in 16 languages).

Founded in 1988, DocuWare AG is based in Germering near Munich, Germany. The company’s US subsidiary, DocuWare Corporation, is located in Newburgh, New York and is responsible for all activities in The Americas. Additional subsidiaries are located in the UK, Spain and France. DocuWare solutions are available through its worldwide independent reseller network of over 400 Authorized DocuWare Partners represented by more than 1000 experts who bring DocuWare close to its customers. For more information on DocuWare, visit our website at www.docuware.com.




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