IBM ApplicationLifecycle Management or ELM Engineering Lifecycle Management for Medical Devices IEC 62304 ISO 13485 ISO 14971
IBM ApplicationLifecycle Management or ELM Engineering Lifecycle Management for Medical Devices IEC 62304 ISO 13485 ISO 14971
Inspired by the evolution of smartphones, Fagor Industrial decided to launch a first-of-its-kind touchscreen washer extractor. With a short window of opportunity before competitors introduced similar products, the company achieved a rapid time-to-market by working with ULMA Embedded to develop the embedded systems using IBM® Rational® solutions.
Fagor Industrial spotted a chance to excite customers with a never-before-seen touchscreen washer extractor. To gain first-mover advantage, it needed to design and launch this innovative product fast.
To achieve a swift time-to-market, Fagor Industrial engaged IBM Business Partner® ULMA Embedded to develop its cutting-edge product using sophisticated IBM Rational development platforms.
reduction in time-to-market, enabling Fagor to gain first-mover advantage
faster development of new embedded systems for a state-of-the-art product
huge time and cost savings by reducing the need to build physical prototypes
The success of touchscreen interfaces on smartphones has led to increasing numbers of other devices adopting touchscreen technology—including laptops, cash registers, ATMs and even cars. Observing consumers' keen appetite for touchscreens, and the greater usability they afford, Fagor Industrial set out to capitalize on this trend by launching an industrial washer extractor that can be controlled via a touchscreen interface.
At the time, no similar offerings were available on the market, but the clock was ticking. Fagor Industrial knew that first-mover advantage would be critical in this new product segment. To seize the narrow window of opportunity, the company needed to design, test and launch its new touchscreen offering as quickly as possible.
“With Rational, we can design and launch new products faster than ever, sharpening our competitive edge.”
— Imanol Lukas Etxarri, Electronic Engineer, Research and Development, Fagor Industrial
Developing a first-of-its-kind product using the latest technologies is always a challenge. For assistance in the venture, Fagor Industrial engaged an expert team from ULMA Embedded, an IBM Business Partner. The ULMA team proposed adopting IBM Rational Rhapsody Designer for Systems Engineers to help accelerate the pace and improve the quality of development.
Imanol Lukas Etxarri, an Electronic Engineer in the Research and Development Department at Fagor Industrial, explains: “We have worked with ULMA Embedded Solutions many times in the past, and they are one of our key strategic partners. When we decided to develop a new touchscreen washer extractor, we knew that it would be difficult, so we engaged ULMA Embedded Solutions to help us on the journey.
“We have a very strong relationship with ULMA because their engineers have an in-depth knowledge of the latest market trends, best practices and cutting-edge development tools. When they advocated Rational Rhapsody for this particular development, we were quickly convinced that it was the right recommendation.”
Previously, Fagor Industrial built new embedded systems by first manufacturing the hardware, then developing the software using the C programming language, running on microcontrollers. Although most of the company's previous products had fewer functions and a simpler interface than the new touchscreen washer extractor, the programming was complex and time-consuming.
In addition, the traditional development process required significant investment in building a physical prototype before the company could obtain feedback on the product from marketing and other departments, and then finalize the design.
With Rational, all that has changed, as Imanol Lukas Etxarri explains: “Rational offers a broad array of advantages in developing a new product. For example, it allowed ULMA Embedded Solutions to begin by designing all of the hardware on the computer, and simulate the results.
“This meant we could show detailed simulations of the new product to our customers, marketing personnel and executives to obtain their feedback. We worked with them to get the look, feel, functionality and usability of the new product right before we built physical prototypes—resulting in major time and cost savings.”
Additionally, the flexibility of the Rational solution made it easy for ULMA Embedded Solutions to develop new functions requested by Fagor Industrial—such as personalized washing cycles—and incorporate them into the new washer extractor's control panel and processes.
As the development team made changes to the definitions of the washing cycles, the Rational software automatically updated any dependent processes—for example, telling the drum when to spin, empty or fill with water. Thanks to this automation, ULMA Embedded Solutions was able to develop the hardware for the new washer extractor 25 percent faster than expected.
Imanol Lukas Etxarri continues: “Thanks to ULMA Embedded Solutions and Rational software, we were able to cut time-to-market by up to 30 percent. Because we launched our touchscreen washer extractor before our competitors brought their products onto the market, we gained first-mover advantage. Our offering has been a hit with customers because it offers a user-friendly touchscreen and helpful features for personalized wash cycles.”
He adds: “With any innovative product, you can expect to encounter some service and support issues immediately after the launch. However, with our touchscreen washer extractor, we experienced far fewer issues than expected. Because we identified and solved many potential problems in the simulation stage, we have been able to achieve a higher standard in the end product.”
In the future, Fagor Industrial plans to enhance its touchscreen washer extractor with internet connectivity, tapping into the trend towards smarter laundries. As a result, customers will be able to control the devices remotely.
Building on its success, Fagor Industrial also plans to streamline the design of future products using Rational, enabling it to respond rapidly to emerging customer demands and hot trends in the market.
Headquartered in the Spanish town of Oñati, Fagor Industrial S. Coop. manufactures products for cooking, cleaning and chilling food on an industrial scale. The company is the leading producer of machinery for the hotel and catering sector in Spain, and is among the top ten manufacturers in this market segment in the world. Employing 1,800 people across eight production plants and 18 sales offices, Fagor Industrial serves customers in 90 countries.
To learn more about IBM Rational Rhapsody Designer for Systems Engineers, please contact your IBM representative or IBM Business Partner, or visit the following website: ibm.com/software/products/en/ratirhapdesiforsystengi
Founded in 2009, ULMA Embedded Solutions specializes in providing engineering services to support the entire lifecycle of electronic products—from concept to manufacturing and maintenance, including design, development and test phases. The company is based in Oñati, Spain. To learn more about ULMA Embedded Solutions, please visit: www.ulmaembedded.com/en
IBM's proven solution for modeling and design activities provides a collaborative design, development and test environment for systems engineers and software engineers that supports UML, SysML and AUTOSAR. It enhances productivity, facilitates team collaboration, reduces time to market and helps improve product quality.
This page provides an overview of the method configurations (process assets) for IBM Solutions.
An IBM® Solution consists of a specific set of IBM tools and associated method configurations that have been developed and tested together to provide a complete lifecycle management solution for a particular domain.
Solution assets are available for:
The method library provided below is available at no extra cost to customers with active Engineering Method Composer or Engineering Method Composer Content Reader licenses.
The WAR files and process templates provided below are free to use under the IBM International License Agreement for Non-warranted Programs.
The practice mappings to standards (DO-178B/C, EN 50128,ISO-26262, DoDAF) provided here can be used to help Licensee meet compliance obligations, which may be based on laws, regulations, standards or additional practices. Any directions, suggested usage, or guidance provided by the practice mapping does not constitute legal, accounting, or other professional advice, and Licensee is cautioned to obtain its own legal or other expert counsel. Licensee is solely responsible for ensuring that Licensee and Licensee's activities, applications and systems comply with all applicable laws, regulations, standards and practices. Use of this practice mapping does not guarantee compliance with any law, regulation, standard or additional practice.
2.0 The assets
A solution asset consists of these parts:
See the Installation instructions below for guidance on deploying and customizing solution assets.
3.0 Detailed Descriptions of Solutions
Each of the solution assets is described in more detail in the following sections.
3.1 IBM Solutions for IT
The following are solutions for IT software development:
3.1.1 Disciplined Agile Delivery
Disciplined Agile Delivery (DAD) is is a process that is based on a core set of agile software development practices that are enhanced with some additional practices that many project teams require.
3.1.2 IBM Solution for ELM
The IBM Solution for ELM leverages DOORS Next, Engineering Workflow Management (EWM), and Engineering Test Management (ETM) to support:
It enables project teams to get up and running quickly. It supports heterogeneous development across multiple platforms and technologies, and it can be extended as your needs evolve.
3.1.3 IBM Solution for Agile ELM with Scrum
The IBM Solution for Agile ELM with Scrum can be used to accelerate the adoption of Scrum, leveraging the automation of Engineering Workflow Management to manage key Scrum artifacts (Product Backlog, Sprint Backlog) and to support key Scrum events (sprint planning, daily scrum, sprint reviews and retrospectives). It provides specialized capabilities for agile team members that improve individual productivity in an integrated environment that maximizes visibility and collaboration. With this solution, governance is “baked in” with templates, process enactment support and in-context guidance that get customers up and running quickly, as well as support for day-to-day usage. If combining this solution with other practices, see How to compose Scrum and other IBM Practices.
3.1.4 IBM Solution for SAFe(r)
The IBM Solution for SAFe(r) can be used to accelerate the adoption of SAFe, leveraging the automation of Engineering Workflow Management to manage key SAFe artifacts (such as Epics, Themes, and Features) and to support key events (such as Kanbans, planning sessions, and retrospectives). With this solution, governance is “baked in” with templates, process enactment support and in-context guidance that get customers up and running quickly, as well as support for day-to-day usage.
3.2 IBM Solutions for Systems Engineering
The following entries are solutions for Systems Engineering.
3.2.1 IBM Solution for Systems and Software Engineering
This solution provides a proven set of best practices for the execution of the Systems development lifecycle. The scope of these practices covers both systems engineering and embedded software development. They have been developed to support incremental adoption, thereby accelerating the adoption of common process support, practices and tools so as to reduce the time to value for the client's process improvement initiatives. The provided configurations cover the Model-Driven Systems Development, Requirements-Driven Engineering and Real-Time areas, and include guidance for both traditional and agile development. More information.
3.2.2 IBM Solution for Aerospace and Defense – DO-178B/C
The IBM Solution for Aerospace and Defense – DO-178B/C is a set of best practices to help organizations develop products for certification under the DO-178B and DO-178C safety critical standards. The scope of these practices covers the 5 main processes described by DO-178B/C, concerning Planning, Development, Verification, Configuration Management and Quality Assurance. They have been developed to support incremental adoption, thereby accelerating the adoption of common process support, practices and tools so as to reduce the time to value for the client's process improvement initiatives. More information.
3.2.3 IBM Solution for Automotive Engineering – ISO-26262
The IBM Solution for Automotive Engineering – ISO-26262 is a set of best practices to help organizations develop products that must comply with the ISO-26262 functional safety standard. The scope of these practices covers areas that are described by ISO-26262, relating to management of functional safety, concept, system engineering, and software development. They have been developed to support the incremental adoption of process, practices and tools, thereby reducing the time to value for process improvement initiatives. More information.
3.2.4 IBM ELM Automotive Compliance
This solution is intended to facilitate setup and use of IBM Engineering Lifecycle Management (ELM) for the automotive industry. This process web site is an example defined process of a fictional automotive company, the JK Automotive Process (JKAP), which implements a systems engineering process using the agile process model Scaled Agile Framework (SAFe). The process was designed with ASPICE base practices in mind. The solution consists of:
The MEC library, templates, and reports are available from your IBM seller as a separately licensed offering.
3.2.5 IBM Solution for Medical Devices
The IBM Solution for Medical Device Development provides support for Design Control, IEC 62304 and Intended Use Validation. Design Control provides delivery processes, work tasks, work products, process roles and guidance that support the objectives, plans, tasks, and work products described and specified by the US Food and Drug Administration (FDA) Design Control Guidance for Medical Device Manufacturers. This mapping aids the development of devices that are intended to be developed, sold or used in the United States and other jurisdictions by providing links between the standard and the process assets that are represented within the Rational Practice library and processes. Specific guidance is given on the application of IEC 62304 which covers software development processes for medical devices. Support is provided for customers to carry out Intended Use Validation of DOORS in the context of their processes. More information.
3.2.6 IBM Solution for Aerospace and Defense – DoDAF
The IBM Solution for Aerospace and Defense – DoDAF (Department of Defense Architecture Framework) is a set of best practices to help organizations develop architectures with DoDAF. The scope of these practices covers many DoDAF work products and specific work flows to improve communication and collaboration between all stake holders in the supply chain who are developing large scale complex systems of systems. The content also has been developed to support incremental adoption, thereby accelerating the adoption of common process support, practices, and tools so as to reduce the time to value for the client's process improvement initiatives. More information.
3.2.7 IBM Solution for Electronic Design
This website includes the practices and the main workflows for Electronic Design with a focus on the high-level modeling of electronic system design and the design management of analog IP Blocks. This content will be of value to teams that face more multisite, multiparty, day-to-day operations for complex design activities. These capabilities help teams communicate and collaborate consistently, save time, and reduce errors and rework. By reducing engineering costs and cycle time, and by increasing design accuracy, more time will be made available for innovation and analog creativity, with the goal to drive quality and differentiation. More information.
3.2.8 IBM Solution for Rail Engineering – CENELEC EN 50128 (beta)
The IBM Solution for Rail Engineering – CENELEC EN 50128 is a set of best practices to help organizations develop products for certification under the EN 50128 safety critical standards. The scope of these practices covers the objectives, plans, tasks, and work products described and specified by the EN 50128 standard They have been developed to support incremental adoption, thereby accelerating the adoption of common process support, practices and tools so as to reduce the time to value for the client's process improvement initiatives. More information.
3.2.9 IBM Solution for Strategic Reuse
This solution describes an approach for facilitating reuse in large-scale product line development. It includes the concepts behind strategic reuse, and and guidance for how to evaluate and incorporate reuse into existing practices. It also includes guidance for using IBM products (Global Configuration Management, DOORS® Next, Engineering Test Management) as part of an overall solution. This solution is intended to guide users to add strategic reuse into their processes, it does not include a complete process solution. More information.
07/15/2020 Updated assets to MEC 7.6.1 and ELM 7.0.1. Removed ISO 26262 solution, which is being merged into the Automotive Compliance offering.
03/20/2020 Updated library to use new product names, fix broken links, and consolidate latest SAFe solution content. Updated the page to use new product names. Replaced reference to ASPICE solution to refer to the new offering that is separately purchaseable.
08/26/2018 Updated library to remove obsolete content (no-longer-sold tools), fixed errors, and included SAFe configuration.
07/26/2018 Updated assets to RTC 7.0.1 and RMC 7.5.3
03/14/2017 Added the IBM Rational Solution for SAFe(r)
07/17/2015 Added the IBM Rational Solution for Strategic Reuse
06/09/2015 Added the IBM Rational Solution for Automotive Engineering – HIS ASPICE (Beta)
01/30/2014 Made the following updates:
IBM Rational Solution for Rail Engineering – CENELEC EN 50128 (beta) – New
IBM Rational Solution for Systems and Software Engineering
– Released 22.214.171.124 version of the library (contains the Rational Method Composer plug-ins for the systems engineering solutions).
– Updated war file for “Agile Embedded”
11/01/2013 Made the following updates:
IBM Rational Solution for Systems and Software Engineering
– New content for Agile for Systems
– New guidelines for DOORS NG
IBM Rational Solution for Medical Devices
– New content for Agile.
IBM Rational Solution for Electronic Design
– New content for Enhanced Defect Tracking
IBM Rational Solution for Aerospace and Defense – DO-178B/C
– prerelease WAR file upgraded to “released”
IBM Rational Solution for Automotive Engineering – ISO-26262
– prerelease WAR file upgraded to “released”
8/12/2013 Added the library for the IBM Rational Solution for Agile ALM with Scrum
6/21/2013 Added new war files for the IBM Rational Solution for Aerospace and Defense – DO-178B/C and the IBM Rational Solution for Automotive Engineering – ISO-26262
5/31/2013 Added the IBM Rational Solution for Agile ALM with Scrum.
1/31/2013 Updated the Systems Solution Library to include the “IBM Rational Solution for Electronic Design” and the “IBM Rational Solution for Aerospace and Defense – DODAF”. These were previously only available in published form.
To browse the published content, you need a web server capable of deploying WAR files. Engineering Workflow Management includes a web server that can be used for this purpose.
To customize the Solution Web site, you require Engineering Method Composer version 7.6 or later. You also require a Engineering Method Composer reader license for each user who browses the customized Solution Web site.
Browsing the solution
The .war file for each solution is intended for deployment to a web server. However, if you just want to browse the web site locally on your computer, you can do so. A .war file can be renamed as a .zip file and extracted with standard utilities.
To browse the unzipped website, open the index.htm file in the top folder with your browser. Some browsers may have issues with file-based browsing.
Deploying the WAR File to a Jazz Server
1.Instructions for deploying to a Liberty Jazz Team Server.
Note that if using dropins, the dropinsEnabled option needs to be set to true in the file JazzInstallDir/server/liberty/servers/clm/server.xml. Also note that for search to work, the war file must be unzipped.
2. Browse the Solution Web site, which is deployed at https://<server_name>:<port>/<application_name>.
For example, if you have installed the Jazz server on your local computer and deployed the clm.war file, then you can browse this site: localhost:9443/clm
Importing the EWM Process Template
See Importing Process Templates. After importing the process template, you can create project areas based on the template. The process templates include work item templates which link to the Solution Web site for process guidance. The links work only if the Solution Web site and EWM have been deployed on the same Jazz server. If the Solution Web site was deployed with a different context URL, you can either export and modify the work item template XML, or generate new work item templates as described below.
Customizing the Solution using Engineering Method Composer (MEC)
To customize the solution website:
1. Download the library .zip file.
2. Unzip the file.
3. Open the library by using MEC version 7.6 or later.
4. Make changes, publish a new Solution Website, and generate new work item templates.
When using content from this library, you must have an Engineering Method Composer Content Reader license for each reader of the content. For details, refer to the Engineering Method Composer license agreement.
|IBM Software Support Communities|
Support Portal: Click the Support Portal tab above to begin configuring your support portal experience to review FAQs, lists of known problems, fixes, and a wealth of important support information. developerWorks: Click the developerWorks tab above to access the IBM RFE Community. Jazz Community: Click the Jazz Community tab above to interact directly with the Jazz development teams and other community members, download product trials and betas and track developement progress. Helpful Hints For Obtaining Technical Assistance: Before you contact IBM Software Support, gather the background information that you need to describe the problem. When you describe a problem to an IBM software support specialist, be as specific as possible and include all relevant background information so that the specialist can help you solve the problem efficiently. To save time, know the answers to these questions:
What software versions were you running when the problem occurred? Do you have logs, traces, or messages that are related to the problem? Can you reproduce the problem? If so, what steps do you take to reproduce it? Is there a workaround for the problem? If so, be prepared to describe the workaround.
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