Requirements Management

impact analysis cover blogWhen a requirement changes, dependent items may be impacted. Without a full understanding of a requirement’s dependencies, there is an increased risk of making uninformed decisions about implementing changes. An overlooked dependency can quickly cause a ripple effect of missed changes, ultimately resulting in schedule overruns and scope creep.

TestTrack’s impact analysis capabilities can take the guesswork out of understanding and approving requirement changes by helping you quickly understand the scope of changes in the context of the entire project.

Download this guide and learn:

  • Why to perform impact analysis
  • When to perform impact analysis
  • How to perform impact analysis with TestTrack

Download your free copy and learn how to make informed decisions with TestTrack’s impact analysis capabilities.

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We’ve made breaking down requirements much easier with TestTrack 2014.1. Now you have the ability to create requirements and tasks from another requirement with a single click. Let’s take a simple example, where you’re creating system specs from product requirements and then breaking down each system spec into a set of tasks for the team. Using Item Mapping Rules, you can quickly create the logic necessary to enable single-click creation of a task from a system specification.

ReqBreakdown

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Trace Early, Trace OftenMore and more companies are finding that building their trace matrix early, and maintaining that information throughout the development cycle, can greatly improve their development process. Early in the process, the trace matrix improves the collaboration between design and verification resulting in more efficient and effective testing. By incorporating risk and hazard artifacts into the matrix, it also helps the team to better mitigate hazards and prove their risk-based approach to the FDA.

Matt Harp takes a deeper look at the benefits you can gain by completing your trace matrix earlier in “Trace Early, Trace Often to Improve Your Development Process,” an article on R&D Magazine’s web site. Take a few minutes and read it now.

How early in the process do you create your traceability matrix? At the beginning of a project, so you can take advantage of it throughout the development process? Or do you wait until the end, and generate it as an item on your compliance checklist?

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In our recently completed 2013 State of Medical Device Development Survey we asked medical device professionals, “What are the top three pieces of information or insights you wish you had better visibility into during the design control phase?” The most common response? Risk controls!

If you look at the responses to another question we asked about how teams are managing their risk artifacts, you won’t be surprised that folks are struggling with visibility into those artifacts. Almost 90% of teams are using documents to manage risk identification, analysis, and mitigation.

Tools for Risk Identification and Mitigation

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Seapine’s recently completed 2013 State of Medical Device Development Survey gathered insight and feedback from more than 400 individuals working in the medical device industry, covering all organizational levels and roles within the medical device field. In addition to general questions about the way folks are developing medical devices, we drilled down into their practices and challenges in three key areas; risk control, design control, and quality control. If you’re interested in how your processes compare to our industry benchmarks, download the full report.

Better Visibility

Specific to design control processes, we asked a few questions that are highlighted below along with response data. The first question centered around visibility into project assets. Sadly, survey results indicate most teams don’t have real-time visibility into their data, and must track down and dig through multiple documents to get that information. Not only is this time-consuming, but it often results in incomplete or outdated information being used to make decisions.

Top 3 Visibility Challenges During Design Control

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Thanks for everyone that participated in the “Beyond FDA Compliance Webinar: 5 Hidden Benefits of Your Traceability Matrix” webinar.  The webinar recording is now available if you weren’t able to attend or if you would like to watch it again. Transcript from the webinar Q & A follows.

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On Thursday, September 19th at 10 a.m. PT/ 1 p.m. ET Seapine is sponsoring a free webinar with guest speaker Steve Rakitin, president of Software Quality Consulting. In this webinar Steve will highlight 5 hidden benefits of your trace matrix that can help you:

  1. Plan and estimate testing and validation needs
  2. Ensure all requirements are implemented
  3. Verify that all requirements have been tested
  4. Manage change throughout product development
  5. Provide evidence that hazard mitigations are implemented and validated

Make sure to register for this informative, free webinar to learn how to take your trace matrix from a regulatory necessity to a valuable tool in your development process.

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When you’re contemplating new features for a device or dealing with the need to change existing requirements, the impact on hazards and risk mitigation can often get lost in the shuffle. If adequate traceability is not maintained throughout the design control process, it can be challenging to identify what risks will be impacted if a specific requirement is added or modified.

In the following video, which is a short excerpt from our recent Leveraging Traceability in Your Risk Management Strategy webinar, Michael Sieve walks through a TestTrack matrix report that makes identifying links between requirements and risk artifacts very straightforward.

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It seems like a straightforward proposition. We have a business problem, and we start a project to address that problem. Business analysts look at the problem domain, interview users, and come up with a set of project requirements that drive a subsequent application development effort.

But what happens in larger organizations where there are multiple projects going on at the same time? Especially if the various applications work with one another in some way? It’s possible that some requirements in different projects can conflict with one another, even to the extent of one project reversing a feature required by another.

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In organizations where rushing software out the door is the standard operating procedure, test managers must develop inventive ways to recruit and retain staff, find time to perform the essentials of testing, and ensure that important defects are addressed.

At this week’s Software Test Professional Conference and Expo in San Diego, Seapine Software solution evangelist Peter Varhol and Gerie Owen, testing manager for Northeast Utilities (NU), will be presenting a panel that addresses the challenges these test managers face.
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