IVD at Siemens

Siemens Healthcare in Marburg explores, develops and produces new diagnostic In vitro test methods. With the corresponding reagents they are used to detect diseases faster and more accurate – and to improve the treatment.

Instruction for Use

Siemens Healthcare was no longer satisfied with the creation of the instructions for use (IFU) for their IVD-reagents.
With DOSCO’s support the company decided to change to XML technology. A key aspect was the high proportion of identical or nearly identical information which matter in the different products.

In 2010 the company implemented  XML leading to substantial benefits. The reuse of certain contents simplifies the maintenance of the documentation and due to the standardization there are now uniform designations for ingredients and measurement units. The editing and translation follows a software-supported workflow. Manual work to the layout and formatting has become a task of the past. The IVD application currently supports more than 30 languages with tendency to rise. The translation costs have almost halved.

Reference Guides and  more

Meanwhile, other document types have been converted to XML. These include the Application Sheet/ Reference Guide and the Assay Protocols for the test systems.

In continuation of the path generating the IFU with XML, here too, (language-neutral) data and text content are separated consequently.

As a result, the corresponding documents can be created extensivly automatically and an extensive pool of product and performance data has been created. Its use beyond the documents is the subject of current considerations.

 

In a similar IVD-Project the Material Safety Data Sheets (MSDS) are additionally produced based on the common Database.

This project shows vividly how the introduction of XML and a future-oriented modeling of the data create opportunities for future requirements.

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