|By JCN Newswire||
|June 25, 2014 07:22 AM EDT||
The new version enables even higher-quality development support by making it possible to link not only Microsoft Excel and Microsoft Word files, but other files of various formats associated with the designs that each developer is in charge of, and to check to see just how these files are related. In addition, the status of these files has been made more easily viewable by putting them in a single-view display.
For the medical sector, it is expected that, with the Amended Pharmaceutical Affairs Law(1) going into effect at the end of 2014, even standalone software that stores biological data or displays visual information will be treated as a medical device, making it subject to restrictions on sales and distribution. For that reason, the company has enhanced its sales for the medical industry, as it previously has done for the automotive, precision-equipment, and electronics industries, contributing to the development of high-quality, safe products by customers in all these sectors.
This product will be exhibited at MEDIX, the Fifth Medical Devices Development & Manufacturing Exposition, running June 25-27 at Tokyo Big Sight.
In the medical and automotive sectors(2), both of which deal with human lives, any defects in electronic-control systems or software can be expected to have grave consequences, which is why quality and reliability are especially strong concerns for these products. International standards have been established for both the automotive and medical sectors which mandate documenting designs and ensuring traceability in the development process(3). In the medical sector, revisions to the Pharmaceutical Affairs Law taking effect at the end of 2014 will extend the application of these requirements for medical devices to standalone software, not just hardware. This can be expected to create a need for software development that complies with international standards such as IEC62304.
Since it was introduced in 2011, PLEMIA SQ-Tracer has been used by dozens of companies, and has primarily been used by electronic component manufacturers in the automotive sector. Using PLEMIA SQ-Tracer has enabled each developer working on a multi-developer product to quickly share the design information they saved. In addition, if there is a need for a design change on a component of a project that is in mid-development, this makes it possible to determine what other design components will accordingly need to be changed.
The latest version is designed for increased usability and clearer traceability. Fujitsu has also enhanced its sales efforts to reach the medical sector, to help customers develop high-quality products that comply with regulations.
About the New Version
1.Improved connections by linking different file types
The software connects not only design documents created in Microsoft Excel and Microsoft Word, but also model files for "model-based development"(4), which use a modeling language that is rapidly gaining popularity in software development. This makes it easy to link model files and other design documents.
2.Visual design traceability
The software includes a feature that outputs a matrix form showing the relational status of design-request units and the relational status among design documents. This gives a comprehensive, single-view display of the relationships, and the output form makes it easy to check for traceability oversights during interim design reviews and audits.
3.Easy data interchange with vendors
Design documents are centrally managed on PLEMIA SQ-Tracer V3. To make it easy to exchange data between multiple companies involved in a development project, the new version includes a function that can send and receive design-document data and development-process data in bulk. This enables vendors to return detailed design documents, test results, and other work products as a set, and consolidate them into a company's own development environment.
(1) Amended Pharmaceutical Affairs Law
The Amended Pharmaceutical Affairs Law was enacted in November 2013, otherwise known as the "Law on Assuring the Quality, Efficacy, and Safety of Pharmaceutical Products and Medical Devices (Pharmaceutical Product and Medical Devices Law)." Among other things, this brought into its purview the approval and certification of the production and sale of standalone software.
(2) Medical and automotive sectors
In the automotive sector, the international standard for assuring the quality and safety of electronic control systems, ISO26262, was ratified in 2011. In the medical sector, the standard for safety in software in medical devices, IEC62304, was ratified in 2006.
(3) Development process
The phases of developing a product. Includes a basic design phase, detailed design phase, development phase, testing phase, etc.
(4) Model-based development
A design method in which the design is described not using natural language but using a model (objects). By conducting simulations from the earliest stages of development, it is possible to uncover design defects, and to automatically generate source code from the model.
About Fujitsu Limited
Fujitsu is the leading Japanese information and communication technology (ICT) company offering a full range of technology products, solutions and services. Approximately 170,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (TSE: 6702) reported consolidated revenues of 4.4 trillion yen (US$47 billion) for the fiscal year ended March 31, 2013 For more information, please see www.fujitsu.com.
Source: Fujitsu Limited
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