Thanks to everyone who joined us for our Automating Traceability and Documentation webinar. The recording is now available on YouTube if you missed the webinar or want to watch it again. Q&A from the session follows.
You can manage development, test, and requirement artifacts with TestTrack. All artifacts are stored in the same database, allowing TestTrack to provide complete traceability throughout the product development lifecycle.
This video includes a high-level overview of how TestTrack can automatically link and establish relationships between artifacts. This eliminates the need to manually link artifacts, and the need to know what to update when an item changes.
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?
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponSeapine 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!
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponA 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.
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponWe 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:
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponThanks to everyone who joined us for our When Requirements Change: Continuing to Meet User Expectations with Requirements Traceability webinar. The recording is now available on YouTube if you missed the webinar or want to watch it again. Following is the SlideShare version of the webinar.
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Unlike a wildebeest, your products are unlikely to thrive in the middle of the herd right now. In challenging economic times, your customers start focusing on value and you need to separate yourself from the herd. I was reminded of this earlier in the week while listening to Activision Publishing’s CEO discuss the gaming market. In responding to a question about current challenges in the gaming industry, Eric Hirshberg had this to say (paraphrasing):
It’s really the best of times and the worst of times for the gaming industry. The top 10 titles are bigger than ever and growing, the part of the industry that is struggling is the “middle class of title.” The middle-budget and middle-rating games aren’t seeing as much interest as they did just a few years ago … There’s no way to market yourself out of a mediocre game.
His point was that quality is the key imperative to a title’s success, and that’s something we’re seeing in every industry right now. The products that best meet users’ needs—and do so reliably—are the products that win in this market.
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponIt 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!
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponProspective customers often ask me if there is a way to approve all the requirements in a requirement document at once.
I usually ask a few questions before responding:
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