White Papers for Food and Drug Administration (FDA)

10 Steps To Business-Driven Compliance

Zellerent

A fundamental fallacy is harming large, established businesses and threatening to destroy emerging ones. That fallacy is: when the regulators and their regulations come calling: (1) you must drop everything you're doing and (2) you must comply, comply, comply.The second point is indeed true: you really had better comply. But the first point is not just false, but dangerous. The truth is that you should never drop anything, let alone everything. Rather, you should start using your compliance imperatives to serve your business objectives. Instead of submitting to the tyrannical rule of bureaucratic imperatives, squeeze every drop of value out of them.Our experience is that turning compliance imperatives to your advantage isn't as hard as it sounds.Rather, it's a matter of perspective. If you start by viewing SOX, 21CFR11, HIPAA and other regulatory requirements as the death of your business, you'll never even stop to consider how you can simultaneously create best practices for your business. On the other hand, if you start by asking—even by demanding—maximum value from compliance imperatives, you'll end up making both the regulators and your stakeholders happy. This brief offers you a plain language roadmap to doing
precisely that.

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