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...
Avoiding 21 C.F.R. §820.70(i) FDA Warning Letters
Two years ago, Google announced a new product: Wave. Their (and I use the term loosely, since all new Google products seem to come from the same giant, faceless Googleplex) original goal was to unify messaging – have you thought about how many tools you use to...
IT outsourcing contracts, as noted in a recent blog post, should be treated as living documents -- continuously evaluated, refined, and optimized over time. Not only do business conditions continually change, but it’s also important for outsourcing customers to...
Bugs can be introduced anywhere in the software development lifecycle, from the early stages (requirements gathering etc) right up to the final shipping of the project. The most expensive types of bugs to fix are those introduced earliest and fixed latest. For...
All of us who work in software development want the products that we release to be high quality, and also low cost to maintain in the field. This is no big revelation; it’s common knowledge, and it’s common sense. It’s not clear that there is any silver bullet in...
The core activities of configuration management (i.e. changeset management and release management) are essential to control the changes made to a system and to administer the release of its different versions. However getting it wrong damages your brand, customer...
IT outsourcing relationships can be fraught with challenges, ranging from communications breakdowns between client and provider to issues surrounding performance. If an IT outsourcing agreement isn’t meeting your company’s expectations (e.g. SLA targets are missed;...
In the Beginning In the beginning, there was an idea. The idea took shape and became a project. The project became an application and the application got used. Or maybe it didn't get used. Maybe it was completely the wrong application for the business. Or maybe it was...
When it comes to product innovation and project development, the role of the project manager cannot be underestimated. That's why it's important to take an objective look at the skills and resources available in your organization and determine if a skills gap exists...
Any project can be divided into different parts including requirements gathering, design, implementation, documentation and so on. One key aspect of the project lifecycle is quality assurance (QA), but it's often overlooked. Although almost all project managers...
Continuous Integration is a leading software development methodology whereby new development is constantly being submitted and tested against the main body of work. The goal being rapid feedback on incremental changes, resulting in lower maintenance costs and higher...