In Agile Development in Regulated Environments -- Part 1: Yes, it can work, I covered the common misconceptions about Agile Software Development -- specifically in highly-regulated industries like medical device. The common myth that regulators would not accept Agile...
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...
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...
This week we will change things up a bit and have a look at an IBM/Rational ClearCase utility used for importing files into ClearCase source control. The utility command, clearfsimport, can be used to import any sort of file from a variety of other source control...
When involved in IT strategy consulting services, you need a way to keep track of passwords in a safe and accessible manner. There are a number of different options out there ranging from single machine managers to cloud-based services. The one I found to be a great...
For the everyday user with a laptop or desktop, this article may not apply. And for those of you who have no need to have more than one PC on your desk -- kudos! But from time to time, its necessary to have several PC's on your desk at the same time -- especially...
Product lifecycle management (PLM) systems have evolved from being custom-built, on-premise applications to cloud-based, off-the-shelf solutions. As adoption for PLM in the cloud increases, system validation approaches in FDA/GXP regulated industries have had to...
A critical business challenge for medical device manufacturers as they scale is getting products to market quickly while supporting existing products and meeting FDA Quality System Regulation (21-CFR-820) requirements. To achieve this effectively, Product Development...
An often overlooked part of IT network infrastructure management is network security. The majority of business networks, even for small businesses, have a large variety of heterogeneous devices that are working together to provide the services for the various...
There are things in every system that if they fail will cause the entire system to be crippled. These single points of failure can be hardware based, software based or even people based. If a problem occurs in these sensitive areas then an entire business can grind to...
Does the new trend towards DevOps threaten the integrity of Application Lifecycle Management (ALM)? The very nature of DevOps, which bridges the gap between development and operations through increased communication and continuous development cycles, would at first...
As more and more technology is embedded into products, and software continues its role as the primary driver for product innovation, the domains of application lifecycle management (ALM) and product lifecycle management (PLM) are being placed on an inevitable...
