Down to the wire for draft 1.0

2009-06-29T16:19:00.003-04:00

The authoring team of the Pharma and Biotech Industry Guide to ITIL V3 met today in person, or at least as much in person as we could since some live too far away to come to Massachusetts.

The meeting was very fruitful as much better discussion always seems to happen when you're sitting around a conference room table versus sitting on a conference call with a a million other distractions.

We discussed a lot of different approaches to addressing areas that were common along each area of the drug development lifecycle (DDLC), which is how the book is structured. We want to make sure that the book is comprehensive yet we also want to avoid getting redundant or repetitive about areas of ITIL that will be written about in each chapter. This is especially important when you have different chapters being addressed by different authors.

We decided to cover the high points of the most common areas in the introduction chapter so that the chapter authors can address specifics to their area within the DDLC.

We also had a great discussion about validation and how does ITIL actually trigger or support those projects. Validation is actually a project within the larger project of developing a drug. Good project management will play a role, yet at the same time (for the purpose of this book) validation appears to be at the intersection of the principles of PMI and ITIL and the FDA's requirements.

In the end, we hope that the book provides a common language and approach for both IT and QA because while both groups have a common goal of supporting the drug development through commercialization, they approach it from different filters serving different masters speaking different languages. While this guide is no Rosetta Stone, it will hopefully bridge the gap enough to make life a little easier for all.

(C)Copyright 2009

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Nom De Plume

2009-03-09T13:10:00.007-04:00

Court Square Group recently signed a publishing contract to write the Pharmaceutical and Biotech Industry Guide to ITIL V3. Doesn't that sound like a barnburner?

In reality, we think it's a pretty important subject, even if it isn't the sexiest title out there. The IT Information Library published its Version 3 in 2007 with a pretty hefty overhaul. Their focus is more on business issues as they relate to the ITIL guidelines. It was also announced that there would be complementary guides written for certain industries.

So, being the not so shy type, I contacted TPTB (that's The Powers That Be for those of you who don't have teenagers or post on any message boards or Facebook or the hundreds of other places that suck up your time.) They liked the idea and allowed Court Square to propose the Life Sciences complementary guide based on the drug development lifecycle.

As an aside, I had to make sure I was using complementary versus complimentary in the right format. As I look at it, compliment is "Nice shoes". Complement is "those shoes really look enhance that outfit." So this guide will enhance the use of ITIL for those working in the FDA regulated industries.

We received approval after eight months of legal back and forth (don't ask). I gathered a co-authoring team for some of the best minds out there in both ITIL and Pharma/Biotech and we're about ready to kick-off writing the draft. I'll introduce them to you once their legal teams give permission to mention the company names but I hope that you'll get to meet some of them here on the blog.

It is our goal that this guide will help both IT and QA professionals in these industries develop or enhance their processes and procedures to make their work more efficient while still maintaining compliance.

The book will be published in less than a year and will start off as an e-book. As we get closer, I will have information on ordering. In the meantime, our team will be sharing the trials and tribulations and writer's block stories on pulling this book together. We welcome any suggestions.

In the meantime, maybe we can come up with a sexier subname for the book. Or else I'll see if the team members will pose a cover ala Fabio. How long do you think it will take legal to approve that?

C)Copyright 2009