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We knew we had to do something about it. With no control over regulatory direction, we had to focus on the elements we could influence. Being a young company, we could not afford any stigma associated with human error, so leveling the playing field of project execution seemed a logical start point. The diversity of opinions, inevitable with specialists of different backgrounds and experience, was a risk minimised by the compilation of our regulatory database, ViP Datum. Opinion yielded to fact. The multiplicity of word-processing skills and quirks never ceased to amaze us; we could soon guess a document author by the style and content of a protocol. But this too became a risk of the past, thanks to ViP Scribe, our automated document generation system. Variety succumbed to uniformity.

Adding compliance training to the equation diminished the risks even further.

The same risk-reduction formula was rolled out across the gamut of our validation and regulatory compliance activities, rapidly becoming a company policy, a guiding principle even more applicable today.