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GxP CLOUD VALIDATION – WHAT SHOULD YOU LOOK FOR?
COMPUTER SYSTEMS VALIDATION IN THE CLOUD – THE BASICS There is an upsurge of interest amongst pharmaceutical, medical device manufacturer to move validated applications to the cloud. These applications often support Quality, Safety, and Clinical processes in accordance with FDA regulations. Although there is a wealth of information available regarding the validation of on-premise applications very little information is shared about[…]
AGILE SALES
Most of us think of sales as a random transaction: the salesperson gets out there and sells, and the customer, in a somewhat mystifying way, decides whether or not to buy. It’s been like that for as long as goods and services. So how does this time-honored process relate in any way to a manifesto[…]
Understanding SaaS Validation
Understanding SaaS validation and what it means for your migration. SaaS is a means of delivering software applications in a whole new way as a service. Well its not new, but combing the cloud with the concept of Commercial off the Shelf Software (COTS) or packaged software is certainly the latest trend. Delivering and managing[…]
3 Secrets from the Agile Success Archives
Consultants and analysts are quick to tell you what makes up a successful Agile team. They talk about buy-in, self-organizing teams, and leaders who resist the urge to micromanage. They profess the importance of cross-functional teams and back-log management. But all successful Agile teams, no matter the industry, share a few things in common: 1.[…]
Tribal Leadership & Systems Thinking
If you haven’t read the book Tribal Leadership by Dave Logan, John King, and Halee Fischer-Wright, you should add it to your summer reading. It’s a fabulous read that uses an analogy of tribes to describe organizational culture. In this book, the author, Dave Logan describes how to assess an organization’s culture on a scale of 1[…]
Stakeholder Engagement – Regulated Industries & Aging Technology
Let’s talk a little theory, and some reality based best practices from the field. The Evidence There is strong evidence in favor of engaging many different stakeholders in decision making . A Study at the University of Berkeley California, contains several reasons why including others in decision making works. Below is a list of the[…]
Breaking Down the Manifesto Part II
Working Software over Comprehensive Documentation If there were a country song for the second part of the Agile Manifesto it would be this one: “A Little Less Talk and A Lot More Action.” In other words, if you want to deliver excellent software, spend more time and energy on actually developing it and less on[…]
Breaking down the Manifesto, Part I: People and Interactions
In 2001, a small band of programmers and software developers got together at Snowbird ski resort in Utah to have fun and share stories. They ended up drafting the equivalent of the Magna Carta in the world of software development. Coined “The Agile Manifesto,” this document now governs the lion’s share of project management and[…]
Agile Transformation
Traditional waterfall projects follow a process very much like a relay race. One runner can’t take off until the person before him hands him the baton, just like waterfall work flows from one finished phase to the next. Agile is more like a team running as a group, with each player tossing the baton back[…]
Agile: The Force behind Salesforce
When Salesforce made the decision to ditch its old process and use Agile as its guiding force, the company was changed forever. Like many of its comrades in the early days of cloud-based software, their releases started to show signs of poor execution. Once the company started to grow, it was no longer able to[…]