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DocuWare 5 Meets Guidelines of FDA

16 Jan, 2007

DocuWare 5 Meets Guidelines of FDA

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 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 Processes meet Regulatory Compliance
The audit was conducted by META Solutions Inc., a consulting company specialized in the pharmaceutical and food processing industries. At DocuWare’s Germering/Germany 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. 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.

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