DocuWare 5.1c Meets Guidelines of U.S. Food and Drug Administration

Newburgh NY (I-Newswire) August 17, 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.

About DocuWare:
A world leader in Integrated Document Management, since 1988, DocuWare automates business processes by easily and securely managing and sharing any type of document, regardless of format or source, in one central document pool. Using the web, documents are even available around the world, around the clock to authorized users.

Company Contact Information
DocuWare
Mary Williams
356 Meadow Ave.
12550
Phone : 845 563-9045 ext 224