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Posts Tagged ‘sdlc’

How Are GAMP 5 And 21 CFR Part 11 Related, If At All?

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: What about GAMP 5? How does it fit into 21 CFR? How to combine both? 

The Trifecta Of Validation

Validation. Admit it – you cringed a little. It’s almost like a dirty word in our industry. That thing that slows down system implementations. That thing that adds a bunch of time and cost to IT projects. That annoying, but necessary, evil. Well, okay, it’s not really “evil,” per say. It is, after all, designed […]

The Importance of Software Process Improvement – It’s the journey, not just the destination.

All great endeavors start with a question. In this case it’s the same question every business asks at some point regardless of their industry or position they occupy. How do we get better at what we do? This is as true for a software company as the business down the street that makes canoes. The […]

12 Things to Get Your Portal in Production Quickly: Part 12 Use an Iterative Development Methodology

Mention of the word, “methodology” need not elicit groans.  Without a repeatable approach to projects it’s easy to miss key requirements, expectations, errors, etc.   So use a software developer methodology for your project. Which methodology to use? Frankly, I don’t care which methodology you use as long as it’s not a waterfall methodology.   I’ve been […]

Requirements Driven Software Development Must Die

Brad Nunnally in our User Experience group pushed this out to a bunch of people via Yammer which we are starting to use a bunch.  Anyway, Fred Beecher does a great job of describing the pains of using a requirements driven approach and where it fails.  He also has a nice graphic outlining a hybrid […]