Quality Risk Management: Looking North

Kevin North is a busy guy. As President and CEO of software and solutions provider Dyadem, he's no doubt got a lot on his plate, and has overseen the growth of a company whose products have been winning awards and winning converts among pharma Quality professionals. North was also a finalist this year for Ernst & Young's Entrepreneur of the Year.

All of which meant that I wasn't surprised when my list of questions to North about Dyadem and its pharma initiatives went unanswered for a few months. He did, however, promise that he would answer them when he could. True to his word, North followed up with me this week. Here is our conversation on Quality Risk Management, and we'll also be following up with Dyadem in the future about another of its core competencies, FMEA.

If there's one thing that strikes me about his replies, it's that the solutions that Dyadem offers are beyond what many manufacturers have even considered as a means of improving QRM and complementing Quality by Design programs. He says:

"Most FDA-regulated companies will tell you that they believe in the FDA’s QbD initiative, but they have a hard time putting it into practice efficiently, especially since many haven’t updated their risk management procedures since the advent of spreadsheet software. Many companies use Excel spreadsheets or customized software for each department and then spend hours trying to cut and paste information together to represent quality for the whole company. Companies that take Quality Risk Management seriously need software that was designed for risk management, not accounting."