The risk-based approach to CGXP compliance required by regulatory authorities over recent years is what we, at ViP, recognised as the only sensible option, when we started up, back in 1995.

Then, regulatory compliance was a much riskier business than it is today.  The success of a compliance project was wholly dependent on the personal regulatory knowledge, documentation skills and attention to detail of, what in those days was, a limited number of, predominantly self proclaimed specialists.  With formal regulatory guidance and comment still thin on the ground, interpretation of the requirements was largely educated guesswork, and, with no formal qualifications then attainable, the term ‘educated’ was largely subjective.

Let’s face it, the road to compliance was paved in risk!