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DocuWare achieves FDA compliance

DocuWare 5.1c, the latest version of the integrated document management software, has been approved as FDA compliant, following an audit conducted according to regulations set forth by the FDA. The 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 US 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.

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 scrutinised.

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.


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