Long Time

I have been very busy lately and I did not had time to write here. Shame on me.

Thru those last months, I have faced many times the same situation again: users and managers are loosing the business focus and get an IT-Database approach that is always the low road.

If you want to aim high, pharmacovigilance should always be first about business (as in business process).


As an example, an organization tried to get the events in a case re-ordered after the case was medically evaluate. The reason was they thought using a dedicated procedure capability in their software will help supporting it.

I had to detail why they were wrong. I have not detailed it from an IT perspective (the call they wanted to use was supposed to be a function and not a data updating feature), I took the business road: why is it done AFTER the medical evaluation and not BEFORE?

By putting the discussion on the right level (business) I put them back on the road they should not have left. My approach was acknowledged as the safest (audit anyone?) and the technically meaningful (updating data when you're allowed to).

I hope you will remember that the next time you talk about a software capability in your pharmacovigilance system.