The value system and practices that embody Agile Software Development have been around for well over a decade, and have been touted as having "crossed the chasm" by organizations such as the Agile Alliance, Gartner, and Forrester Research. Numerous studies indicate...
Redundant and repetitive tasks present a number of challenges for your business. Your engineering team feels bored, like they’re wasting their time. Pretty soon, they’re done being bored and looking for more challenging and rewarding work. With skilled engineers in...
Requirements management isn’t optional in many fields. Medical technology and finance are just two fields where regulatory compliance necessitates requirements management. You and other stakeholders simply must be in total agreement about the requirements of a given...
Automation isn’t just for manufacturing tasks. In fact, many of the grinding, repetitive tasks your engineers can’t stand can easily be automated out of existence. Any task that is repeatable is automatable. That means you can save big money on man hours, letting your...
Welcome back to our series as we continue to examine the 12 principles underlaying the Agile Manifesto! Our topic for this installment is principle six's guidance on effective communication. This principle states the following: The most efficient and effective method...
This installment of our 12-part series on the principles of the Agile Manifesto deals with principle 7. This principle states: Working software is the primary measure of progress" In a traditional waterfall development cycle, all the design is done up front and the...
Many of you are undoubtedly familiar with using Jira as an issue tracker. But for those of you who have been juggling issue tracking and meeting SLA requirements -- and for those of you who had the recently acquired VertygoSLA addon -- this article may be useful...
Everyone loves a one-click installer, but setting this up can be a headache, especially when a company changes the way this is done. You can setup your installation script to install both PADS9.3 and PADS9.3_update1 with a double-click of the mouse! Here are the first...
This week we want to have a look at a useful website that enables us to quickly and accurately install any of a large number of useful software packages. The website, www.ninite.com, presents a large number of current freeware packages, along with trial versions of a...
Download the Requirements Traceability Report This report starts with a Market Requirements document, and traces down to the Tests and Test Results. Sheet 1 covers compact categorization, where the artifacts are basically defined by the Document types. Sheet 2...
SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends. One of the problem areas most often cited in company audits continue to be the CAPA system/program. This month we will take a look at some of the latest FDA...
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
