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Quality Management Audit Confirms:

windream GmbH Complies with the Requirements of the Pharmaceutical Industry


Within the regular review of our quality standards, windream has successfully taken part in an audit in which specifically the compliance of the quality management regulations of the pharmaceutical industry has been tested and evaluated very detailedly. The report, created by an independent auditor, comes to the conclusion that windream GmbH fulfills the QM Requirements of the pharmaceutical industry.

Audit Report Honors an Excellent Overall Impression

The audit which lasted several days took place in January at our headquarters in Bochum. A special focus was on a detailed review of quality management processes, on product development processes, the process documentations involved and the specific quality ensuring measures.

The QM auditor determines that our quality management overall leaves a “very good “impression. Especially the very efficient cooperation of product development and quality management was praised. In this context the communication between the members of the development department and the integration of the quality management into the flow of information of the development processes is said to be “excellent”. Furthermore, the intense software tests that are performed on several levels within product development are seen as a positive aspect. The internal quality assuring measures include testing of every single software module as well as integration and overall tests of a new or extended product. The development of new software solutions in our company is performed via the so called SCRUM method, representing an agile procedure model for realizing software development projects.

The report furthermore states that the error rate in the software has been reduced to a minimum by this intense and extensive test processes. Last not least the QM auditor comes to the conclusion that the preventive security measures windream has established for data security are “state of the art“ to quote the text literally.

Background: Compliance with the Internationally Valid FDA Rules


The audit furthermore was the basis for determining of conformity with the US „Food and Drug Administration“ (FDA). In the so called “Title 21 Part 11“ of the “Code of Federal Regulations“ (CFR), this authority has documented regulations for storing and managing electronic records in the pharmaceutical industry. Conformity with these regulations is of special importance for our windream Partner BioMedion GmbH from Berlin (www.biomedion.com), an enterprise of arivis AG, Unterschleißheim. BioMedion has developed “BM Flow“, a Software solution for managing controlled documents, trainings, QS processes as well as device data based on the windream ECM System. The software is used in several pharmaceutical companies of all sizes and therefore bound to the compliance with the FDA regulations.

 

Further Information

windreamNews 02/2016
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