Monday, January 15, 2007

GMP, GLP why not GSP?....Gee, I don't know!

Happy New Year! New Year's is usually a time for resolutions. I don't believe in those, if something needs to be changed, why wait a whole year to do it, especially since you'll break it in two days anyway. (Probably because you were very…..tired….when you made it in the first place.)

But in some cases, the new year is a good time for a fresh start. So with that in mind, Court Square in the Round would like to tell you about something the company is always taking about and that is Good Systems Practice or GSP. We believe GSP is a fresh approach to IT Service Management, especially in regulated industries. It has become our mantra. No, we haven't had any employees sitting around the lobby in the lotus position, burning incense and chanting GeeeSsssssPeeee. (Really. I just checked. Besides, I think it is against the fire code.) But it has become a critical piece of the way we support our clients and help them establish an IT environment that supports their business goals and audit requirements. It helps IT add value to the business so that the CFO doesn't get out the red pen to slash the budget once again.

What is GSP? It all started a few years ago when we were talking about how our pharmaceutical customers have the FDA mandating disciplined approaches to segments of their business such as GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice and GCP (Good Clinical Practice). Someone in the room (I think it was the CEO and for the sake of totally sucking up, let's just say it was the CEO) wondered out loud why no one at the FDA had ever gotten around to doing the same for IT, since so much of all of those other processes are tied together by IT and all the data generated is so critical. We'd been supporting pharma for years with a methodology that mirrored ITIL, which was just beginning to catch on in the US. So, why not propose it as a Good Systems Practice?

As an aside, I read an interesting take on the difference between ISO and ITIL the other day. I was googling around looking for other people's take on it and found it on a message board of all places. I can't give proper quote credit because I think the person's screen name was ILUVITIL or something like that but basically they said that ISO makes sure that you do what you say you are doing but ITIL makes sure what you are doing is right in the first place.

It all starts with aligning IT with the business goals, which the newest version of ITIL (V3) is moving toward. It builds like layers of a pyramid. Best practices from ITIL and the Project Management Institute create the foundation. The processes and procedures are layered on top of that, with a focus on Service Level Agreements (SLAs). It is only then that automated tools come into play. Too many people jump right to tools. But just like the pyramid, the middle layer does not belong on the bottom. That's an expensive way to fail because you just get to see your bad processes in action that much faster. Sort of like a really ineffective closing pitcher coming in during the second inning. After you implement your tools, train your people and start monitoring your progress. It sounds easy right? OK, it's not easy but it is easy to follow.

We decided to share this with others in the pharmaceutical industry to see if we could gain some traction adopting a standard methodology. Pharmaceutical Technology published a "call to arms" by our CEO in 2005. I really wanted to have a picture of him on a horse waving a sword or something but we didn't have a horse in the supply closet. (The scary thing is we did have a sword.) My second choice was the blue paint and kilt from Braveheart but in the end we settled for a typical corporate headshot. Luckily, the call to arms was greeted with a very positive response anyway. As it turns out, there is a group composed of members of the FDA, pharmaceutical companies and service providers like us who are looking to do the same thing. So, we are thrilled to be participating with them.

Since that time, we've been invited to speak at various events on GSP including the latest FDAnews conference. It's exciting and we hope you will join us. We've got information on tools and whitepapers on our corporate website at www.csdg.com Or if you don't find what you need, just email me at blog@csdg.com and I'll send you the pyramid or a GSP maturity model to help you gauge where you are today. (As it relates to GSP, I can't help you with your personal level of maturity. Although maybe we'll make that an end of year blog.)

One more thing, we've trademarked GSP and Good Systems Practice so feel free to use it with proper credit. The penalty for failure to do this is being strapped to an uncomfortable office chair with an ipod secured to your head and the playlist selected by a group of teenagers.

Stay tuned to more on the subject, including discussing how IT and Quality can get along better after GSP. We'll call it the IT versus Quality Celebrity Death Match.

The Marketing Maven


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