DocuWare 5 Meets U.S. Food and Drug Guidelines

Standard Package FDA Compliant

DocuWare submitted its integrated document management system to verify compliance with guidelines set forth by the U.S. Food and Drug Administration. DocuWare 5 meets all requirements of this U.S. government agency that oversees and approves food and medical products. This means that this standard software package may be used by companies closely regulated by the FDA in the pharmaceutical and food processing industries replacing the need for expensive, custom solutions.

The U.S. market is strictly regulated, to enforce legislation and protect American consumers. The Food and Drug Administration (FDA), for example, regulates the manufacturing, storing and sales of products in the pharmaceutical and food processing industries. 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 submitted the newest version of its DocuWare integrated document management software under the FDAs 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 Processes meet Regulatory Compliance

The audit was conducted by META Solutions Inc., a consulting company specialized in the pharmaceutical and food processing industries. At DocuWares Germering/Germany headquarters, all of the companys internal processes regarding software development, service and quality control in addition to the programs functionality, were closely scrutinized. In particular, the high level of operational security provided by DocuWare and its support of all types of electronic signatures along with tamper-free archiving and detailed documentation of all processes satisfied the regulatory compliance required by the auditors.

At the end of the audit, the consultants prepared a White Paper demonstrating that DocuWare complies with all of the guidelines set forth in FDA - 21 CFR Part 11. The results of this audit are included in the DocuWare AG Regulatory Compliance Follow-up Audit Report prepared on December 11, 2006.

Document Management System for All Industries

By meeting FDA regulations, this integrated document management specialist has again demonstrated that its standard software package, DocuWare, can be used in companies of all sizes and industries. Even internationally pharmaceutical and food processing companies who are looking to automate and improve workflows for the long-term with document management, can find an ideal solution in DocuWare. It contains all of the components for powerful Enterprise Content Management yet remains easy to install, administer and use.


DocuWare The Company

Founded in 1988, DocuWare has over 6,000 installations with tens of thousands of users in over 50 countries.  DocuWare offers a scalable solution that can expand enterprise-wide.  Over 400 Authorized DocuWare Partners make up a worldwide independent reseller network, employing over 1000 DocuWare experts who bring DocuWare close to its customers.

DocuWare AG is based in Germering near Munich, Germany.  The companys US subsidiary, DocuWare Corporation, is located in Newburgh, New York and is responsible for all activities in North, Central and South America.  DocuWare Ltd., its subsidiary in London, handles all activities for Great Britain and Ireland. DocuWare Espaa located in Barcelona is responsible for the market in Spain.


DocuWare Software for Integrated Document Management

DocuWare is an integrated document management solution that can automate business processes by managing any type of document, regardless of format or source, in a central document pool for example paper records, letters, faxes, drawings, PC and other electronic files including e-mail.  DocuWare supports all forms of electronic signatures.  Integrated records management ensures that all access is secure, controlled, and logged.

Using the Internet, the central document pool is available around the clock to any authorized user, no matter where they are located in the world.  A wide range of customizable DocuWare add-on modules equip DocuWare for, among other things, automatic indexing, COLD applications and enhanced workflow features.  Other software applications are easily integrated with a set of standard tools.  Numerous interfaces exist for ERP systems (including a certified SAP interface) and Groupware (like Exchange or Lotus Notes/Domino).  DocuWare incorporates all components needed for powerful Enterprise Content Management.  Processes in every company can be automated and improved with DocuWare.  DocuWare solutions are known for their easy installation, administration and operation, as well as an exceptionally low Total Cost of Ownership (TCO). DocuWare software is available in 13 languages.

Enhanced with workflow functionalities, Web Content Management, and universal integration functions, DocuWare provides powerful Enterprise Content Management (ECM) functionality for enabling expansion throughout an organization.

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