The Seapine View

Remember when you used to be able to track test cases and pass/fail results in a simple spreadsheet? It took all of 30 minutes a week to update the data, and no one asked for it more often than that. However, over time, the need for more precise and timely test information grew and the spreadsheet grew too. At the same time, the applications you test also became more complex. You started with 100 test cases but you’re currently up to 400 and counting.

Your spreadsheet now includes more information about each test case, such as when a test case was run, how long it took, where it failed, if a defect report was created, how long it took the defect to be resolved, and much more. That spreadsheet now has several dozen columns, with a jumble of dates, numbers, and text. You can’t easily view or report on the data you’re tracking.

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Do requirements still matter in an Agile environment? What is the business case for Agile, and why is the market moving toward Agile solutions? Agile experts from Seapine Software will answer these questions and more at the TechNet-Aero Conference in Dayton, Ohio, October 17-20.

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Thanks to everyone who joined us for the FDA Design Traceability Requirements for Device Development webinar with John Avellanet, Managing Director & Principal at Cerulean Associates, LLC and Larry Nicholson, Business Development Manager for Life Sciences at Seapine Software. If you missed the event, or want to watch it again, the recording can be found below or viewed on SlideShare. Additionally, you can download the FDA Expectations for Traceability in Device Design slide deck.

Q&A

Where can I find the FDA draft document for medical applications?

All of the recent medical device guidance documents can be found on the FDA site: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm162707.htm. (Avellanet)

Is an application that sets up datasets for infusion pumps considered a medical application?

Take a look at the guidance, specifically at the criteria listed on pages 13-15, and then the examples provided by the agency in Appendix A of the guidance. (Avellanet)

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Last chance to join—Seapine’s TDD 101 webinar series starts on Wednesday! In case you haven’t heard, our latest webinar series is targeted at helping you improve your test-driven development skills. The series is being led by Katie Dwyer, who is an Agile Services Consultant in Seapine’s Agile Services group.

Katie is going to cover the following core topics over the course of three classes.

1. Intro to Test-Driven Development
2. Writing Good Unit Tests
3. Beginning TDD in a Legacy System

BONUS: If you’re not able to commit time to attending the free classes, download our new TDD Reference Card to help you start using TDD effectively.

We recently compiled and analyzed the results from a survey aimed at understanding how life science organizations are managing core product development artifacts and proving traceability. The results showed that most are still using Microsoft Word and Excel to manage and trace artifacts—at best storing documents and artifacts in a document or quality management system. I wonder how these organizations manage to tie all the documents together and prove traceability with the FDA?

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For the eighth year in a row, Seapine Software has been named by SD Times as one of the Top 100 companies that “write the code that makes the whole software-development industry succeed.” Seapine was recognized in the ALM & SCM category for offering a suite of solutions that encompasses the entire development lifecycle.

“We’re incredibly honored to be in SD Times 100 for eight years running,” said Rick Riccetti, president and CEO, Seapine Software. “Our goal has always been to help our customers develop quality software, and being chosen again and again by SD Times makes us feel like we’re accomplishing that goal.”

Read more about the SD Times 100.

Seapine Solutions Evangelist, Peter Varhol, was recently interviewed about requirements traceability by Mike Lippis for the Outlook Series. The “Strengthened Traceability Drives Greater Quality & Communication” podcast is now available.

Peter and Mike discuss several aspects of requirements management, and why traceability is so important to the software development process these days. Following are a few interesting nuggets, if you don’t have time to listen to the 46-minute interview:

01:30 - Definition of requirements traceability

09:50 - How to make traceability automatic

21:55 - How to know if your traceability strategy measures up

30:00 - Information about managing requirements traceability with TestTrack

Have an opinion on traceability, or a story about how your team uses traceability to improve quality? We’d love to hear it—leave us a comment!

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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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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“We’re overrunning our schedule and we have to go live now. I know the software’s not perfect but it must be good enough…right?”

If you are responsible for quality that sort of question can be a tough one to answer. Often, there can be a lot of pressure on you to agree that the software is done even if it’s not ready. On the other hand, if you are too cautious you might unnecessarily delay the release which will incur unnecessary costs, miss opportunities, and ultimately the quality team may end up being seen as a hindrance and source of delay.

So how do you decide when it’s the right time to ship? Continue reading…