The Seapine View

Why a deceptively simple solution to one of Waterfall’s deep flaws makes it no match for Agile software development.

Earlier this year, I had the privilege of co-presenting on Agile Software development to a group of computer engineering students at the University of Cincinnati  with our Agile Padawan, Katie Dwyer. Walking through campus was a refreshing experience. Seeing all the young faces reminded me of my college days, and the level of optimism, energy, and hint of youthful rebellion that often pervades the student population of many college campuses. Yes, even in a time of economic uncertainty, the spark is still there!

During our presentation, I talked about some of the weaknesses of the Waterfall model and contrasted those weaknesses with the strengths of Agile software development models. At one point, I talked about how Waterfall development includes a predictive model of requirements gathering—where all requirements are gathered up front, interaction with the customer is limited, and change control processes are formalized to limit changes throughout the project lifecycle. In contrast, Agile methods allow daily communication with the customer and frequent changes with minimal constraints.

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Requirements or user stories? Why not both? Attend our Requirements and Agile: Keeping up with Change webinar on October 4, at 1 p.m., to learn how to minimize gaps in verification and validation practices sometimes seen when using Agile methodologies. These gaps are typically a result of moving away from formal requirements in favor of user stories, which are quicker to develop but typically not as rigorously defined.  Continue reading…

While Agile has been gaining more and more ground, it appears that many organizations are also adopting their own flavor of Agile. They take the parts that they like or work for them and integrate them into their own process. Sometimes this is driven by outside factors, like compliance needs and customers.

In these instances, you may have a need to manage both requirements and user stories in the same project. In this post, I’ll talk about one way to do this in TestTrack.

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A look at a common question of start-up medical device and other regulated companies that want traceability, but don’t know when to start.

I’m often asked, “When is the best time to get my development artifacts in order?” The short answer is there isn’t a best time. But, the better question is, “How can you afford to wait?”

In the life sciences sector, companies must prove that good processes were used in the development of a product. If you know you don’t have good processes, or you have a lot of manual processes, it’s likely you need to get your development artifacts in order now.

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TestTrack RM includes support for importing requirements from Microsoft Word documents. You can specify how your requirements are stored in your Word document to ensure proper parsing of your document. You can also preview your requirements before they are imported.

In this video, I’ll show you how to import your Microsoft Word documents into TestTrack RM.

We recently wrapped up development of a workbook with 6 specific exercises to help an organization improve traceability practices. These are exercises that you can complete in as little as a couple hours, or you can break them up and spend more time on each one over the course of one or more weeks. The exercises help your team/company discuss current development and quality challenges, understand overall quality and compliance requirements, and determine best practices to adopt going forward. The goal being to boost quality and improve your compliance with FDA regulations.

I was reminded of the importance of meeting FDA regulations with the stumble at Johnson & Johnson, when their Cordis unit was hit with a 483 warning letter in February. Maybe it’s because of our focus on the traceability workbook recently, but one passage in particular struck me as especially instructive:

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If you haven’t been intimately involved in an application development project, this question probably evokes some puzzlement. You ship your software when it’s done, right? Well, maybe. There are a number of considerations that you take into account when deciding when to ship an application—is the coding complete, is the quality there, and is the business ready?

The developers are responsible for determining when coding is complete, while the business owners have to determine if the application is ready to increase revenue or reduce costs.

I’m interested in focusing on the second aspect—the assessment of application quality. We can point to things like defect rate or requirements met as shipping criteria, but those are still ambiguous terms. Any application is going to have defects, and some requirements will be met better than others.

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It used to be that users, or product management, submitted a set of features and requirements to the development team and waited patiently while development constructed exactly what they asked for. Six months later, when users saw this new application for the first time, they realized that what they asked for wasn’t really what they needed. Something had been lost in the translation from what they needed to what they told development to create, to what development ultimately created. “No problem,” development would say when told the existing software didn’t meet a specific need, “we can change that in the next release.” And six months later, it would indeed be changed!

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In TestTrack RM, the default requirements workflow includes a Review Note event that reviewers use to provide feedback on individual requirements.

Before requirements are approved, it’s crucial to make sure all review notes are addressed. You can make this easier by adding a check box to the Review Note event, which users select after addressing a note. You can also create a filter to display requirements that still contain review notes to address. Users can apply this filter to quickly find requirements that need attention.
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We recently released version 2010.1 of TestTrack, which contains many new exciting new features. One new feature that I would like to give some love to is Item Mapping Rules. This feature will benefit users who have more than one TestTrack applications, as it allows you to configure how field values are mapped from one application to another.

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