Achieving IT Compliance Faster for Less: An Expert Interview
This week we sat down with John Avellanet, Managing Director and Principal of Cerulean Associates LLC, a Regulatory Compliance consultancy and board member of the ICCA.
ICCA: So, tell us why you went into consulting.
John: Well, after I’d overseen the merger of the company where I was CIO, I was offered a position with the new owner –
ICCA: Philip Morris?
John: That’s right. There in Richmond, Virginia. Yet, I realized I wanted to do something more. I’d had the incredible fortune of working with a group of really talented folks, and had struggled through a lot of thorny issues in the medical device design field, in the regulated IT field and had even developed an ISO compliant records management program. So, a position in the IT hierarchy of an established company somehow just didn’t fit with where I envisioned my career going. In the meantime, I’d learned a lot, mastered an intense amount of FDA regulatory compliance rules and practices, and even received a couple of invites to speak at conferences. The more I spoke with colleagues around the globe, the more they urged me to go out on my own.
John: Indirectly, yes. First I took up invites from contacts and interviewed with the likes of Booz Allen and IBM, but the whole time I kept thinking about starting my own firm; not something my wife wanted to hear since we didn’t have a year’s worth of salary savings sitting in the bank. So I spent time writing a reasonable business plan and finding partners who would help fund it – and actually one of my partners pushed for the compliance focus.
ICCA: So you’re an FDA computer validation consultant?
John: I focus more on the strategy and advisory side. A previous client put it this way: when you go to an accountant, they focus on the work of the taxes and the accounting. Yet, that won’t let you plan for retirement, balance your investment portfolio, learn budgeting skills, deal with debt, etc. For that, you need a Financial Advisor. Same thing in the regulatory arena with computerized systems. Most regulatory consulting firms focus on the work of validating systems to regulations, writing procedures, training and auditing; I help my clients take a big picture view and develop flexible Part 11 compliance strategies (and EU Annex 11 compliance strategies) that encompass compliance and business alignment. Thus, I help them work out what to validate, what not to, why, what their options are (outsourcing versus insourcing), and so forth; I then supplement that by helping them with FDA process refinement and defensible documentation.
ICCA: Did you come to this approach on your own?
John: I’d say I was influenced by several mentors, some long-time colleagues and friends, and by the works of Peter Block, Steve Covey and Peter Drucker.
ICCA: Not your typical IT industry authors.
John: Yes, and I should tell you, I’m a big fan of Nick Carr’s “IT is a commodity” philosophy, thus I wrote the article Why CIOs Should Commoditize IT for Bio-IT World.
John: Definitely. I like that Carr makes the case that technology is no longer a true competitive advantage in the 21st century – technology is too commonplace, it’s available to anyone and everyone; certainly that defines Thomas Freidman’s “flat world.” And it’s definitely been my experience. I’m not aware of a technology today that will let you dominate your industry or gain a competitive advantage long enough to make a true profit on the investment. The key now, I think, is accepting Carr and Friedman’s arguments and building toward Block’s “stewardship” ideal.
ICCA: What do you mean?
John: Well, if I know that technology isn’t going to give me a competitive advantage in and of itself, and I accept its ubiquity – everyone has a website, web conferencing, e-mail, etc. – if I accept those two things, then what’s a company left to compete on? Quality and service. So, that’s pretty much the key for Cerulean – a high degree of personal service and quality (including things like innovation, creativity, plain talk, and so on). That’s why I publish our consulting price levels – someone will always be less and someone will always be more, so why bother competing on it. My role is to help my clients make better decisions around compliance, and that holds true for potential clients as well – part of the information they need is the cost for the level of service, quality and advice they’ll get.
ICCA: Thus getting back to the Financial Advisor-type role, right?
John: Correct. And thus Cerulean’s slogan Turn compliance into a competitive edge.Originally published February 2007 in The Independent