Most departmental disconnects that you hear about when talking about IT departments is that the IT group doesn't care about the business. The CFO thinks they are just a big expense line item. Other end users think they just love the bells and whistles of the latest kewl tool, whether or not it renders the system user-friendly or supports the business needs. Haven't you heard or said at least once in your life.. My computer isn't working right, IT must have done an "upgrade" complete with eye roll and that annoying finger quote gesture. In turn, IT people would complain that the end users didn't know what they needed or else they wanted everything.
Thankfully, a lot of this has changed over time as end users become more technology savvy and IT implementations are conducted with more discipline and emphasis on business value. But…there remains one last frontier for a standoff and that's often found in regulated industries such as biotech, pharmaceutical, medical device and to a lesser extent financial services. (Now if this were a podcast, I'd play that western gunfight whistle as two dusty cowboys fingered their holsters and spit tobacco.) Why? Because these industries have big fat government regulations sitting on top of them. Before I get a bunch of emails from government types, I said regulations not regulators.
Let's take the FDA regulated life sciences industries for a second. The majority of the regulations are really meant to ensure drug safety and efficacy. (In other words, they don't want anyone dying on their watch.) But the departmental issues that can bubble up between IT and the Quality group responsible for audit oversight have more to do with a lack of understanding of what each other does than anything else. Sometimes it can be as simple as the IT systems are designed in a vacuum first, especially for a younger company, and then everything has to be redone after the company has moved on to the phase of its lifecycle requiring FDA compliance. It's a pay me now or pay me later scenario with the QA person standing there with her hand out and the IT person pretending he's got dust in his eye and has temporarily been rendered blind.
Sometimes the real issue is paperwork. Happy audits need happy audit trails. (Regrets once again that this blog isn't a music filled podcast) IT people hate! hate! hate! filling out paperwork. I mean, have you ever read about an IT person winning the Publishers Clearinghouse Sweepstakes? But a QA person can get overly paperwork happy as well without really understanding the processes that IT people deal with. This is usually because they come from a manufacturing background, which is often more cut and dry thanks to GMP regulations. But they won't back down from a well-documented process because it’s their butt in a sling. The result is departmental distrust, inconsistent processes, doing things twice, and worse, risks to the audit. All kidding aside, failed audits can lead to things from fines to really bad publicity to problems in drug development or manufacturing and thus a danger to the public. And that ain't good.
So if Good Manufacturing Practice is what's making the QA people a little "inflexible," why not work with that instead of against it? Why not Good Systems Practice too? The FDA wants you to pass an audit but they don't give you too much help in how. Companies develop their own system (if at all) and in bigger companies it can vary from department to department. So the not-invented-here syndrome comes into play. Good Systems Practice, which is based on the IT Infrastructure Library (ITIL), can help both sides be on the same side. It can look at all the company's business requirements (which includes the regulatory side) and build in best practices that meet the audit requirements with the right amount of paperwork, not the right mound of paperwork.
The latest version of ITIL (V3) is due to arrive in the Spring with complementary guides focusing on specific industries (especially the regulated ones) in the future. It's not quite a cookbook but it certainly will go a long way in preventing the cooks from getting out the sharp knives.
For a more detailed white paper on this subject, email me at blog@csdg.com.
The Marketing Maven
(and no, that's not me with the boxing gloves on. Mine are blue.)
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