The Seapine View

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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With all of the hubbub around Yahoo’s announcement to “ban” telecommuting, I thought it might be a good time to highlight some recent customer feedback we’ve gotten on this issue. A new initiative I’ve been leading is engaging with our customers to talk about their corporate strategies and challenges, which we’re feeding into the Seapine roadmap to make sure we’re better aligned with where our customers are heading. Of course, we’re also looking at new and better places to take our customers, that they might not have considered or even knew they would benefit from. P.S. If you want to talk with me and the rest of the corporate strategy team, we’d love to chat for 20 minutes; email me!

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At what point in the process of developing a new device does your team start formally managing requirements and risk?

In talking with medical device companies, the most common answer we hear is “we don’t start worrying about that until the product is actually under design control.” That kind of time frame works great for the engineering side of the business, but often leaves marketing and product management in the lurch. The issue is that product management and marketing do the bulk of work on the front-end understanding the market need, defining a concept, and building a business case for the new product, including:

• Capturing voice of the customer (VOC) feedback
• Determining market/user needs and researching competitive offerings
• Conducting cost and reimbursement analysis

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Thank you to everyone who participated in the Leveraging Traceability in your Risk Management Strategy webinar. The recording is now available if you weren’t able to attend or if you would like to watch it again.

Anyone who has participated in product development projects knows that delivering the right product can be a complex and difficult process. User needs are translated into business requirements, which become design and engineering specifications. A product is then built to those specifications and validated by test cases that are created from the requirements. At each stage of this process, it is possible to lose sight of information important to the product’s purpose.

Linking Requirements

Tracing artifacts in TestTrack is both easy and seamless within any process. You can create and manage requirements or user stories hierarchically, and organize them in TestTrack to define the product or component you’re building. Because requirements can be arranged hierarchically, they are automatically related to parent requirements. If a child requirement changes, or is noted as not met, this hierarchical relationship ensures the parent is also marked as suspect.

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Thank you to everyone who participated in the Gaining More than FDA Compliance Through Traceability webinar. The recording is now available if you weren’t able to attend or if you would like to watch it again.

If you’d like to buy Dave’s book, browse to www.ArtechHouse.com/vogel and use promo code DV25.

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The FDA and other international standards encourage life sciences organizations to adopt strong traceability practices to help with compliance. Once you learn how to capture key data and create reusable, traceable requirements, what does your organization gain beyond compliance? Reduction in design review phases, better impact and gap analysis, and faster V&V cycles—to name a few.

Please join Seapine Software and guest speaker David Vogel, founder and president of Intertech Engineering Associates, on October 18 to learn more about the benefits of good traceability from a practical, day-to-day perspective. David and Seapine will share real-world business scenarios and how TestTrack supports them. Register for the Gaining More than FDA Compliance Through Traceability Webinar now!

Thank you to everyone who participated in the Leveraging Reusability and Traceability in Product Development webinar. The recording is now available if you weren’t able to attend or if you would like to watch it again.

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Creating verifiable requirements for reusability downstream

Please join Seapine Software and guest speaker David Vogel, founder and president of Intertech Engineering Associates, to learn best practices for creating verifiable, traceable requirements. David will share insightful tips to ensure you’re creating requirements that capture key data for enabling traceability, reporting, and metrics for management. The webinar will also include a demonstration of how TestTrack supports streamlining better processes, data capture, reusability, and traceability in the requirements phase and a Q&A session. Register now!

Date: Wednesday, September 13

Time: 10 a.m. PT / 1 p.m. ET

Duration: 60 minutes

When starting an R&D project, your goal is simple—FDA approval. The challenge is how to get that approval without wasting time, money, and resources. You need an integrated framework that enforces how key data is captured, helps you create verifiable requirements, and ensures elements in a requirement or test case can be reused. Otherwise, you risk:

• Unverifiable requirements
• Little traceability between development artifacts
• Lack of visibility into previous assessments and origins
• Missing data that may affect future analysis and risk identification
• No historical record keeping

Register now!

Our graphic designer is on vacation, so I had got to create my own graphics today! My next project is to help repair the “Ecce Homo” fresco that was recently botched in Spain.

The life of a business analyst

What you’ll notice here is that there’s a black hole developing in your BA’s inbox. The better your customers are at responding to requirement reviews, the more productivity is sucked out of their day. Instead of delivering requirements to the development team or figuring out what’s going to be in the next sprint, your BAs are busy reviewing Word documents and making clerical updates.

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