How Does Quality Pulse® Align with ICH Q10

Teresa Gorecki |

Gorecki: Very well. Ken, do you want to take that first? Ray: Sure, I’ll take a stab at it. If you look at Q12 and some of the content that’s in Q12, it talks about risk management and... Read more

Visualizing Quality Culture Data – Analyzing Two Quality Culture Scenarios

Ken Ray |

Now let’s look at a third quality culture scenario, where you have a weak or ambiguous culture. Notice in this one that expressed values is a relatively low score, as is underlying assumptions. But you have very strong... Read more

Quality Culture Scenarios – Good vs. Bad

Ken Ray |

It’s our belief that culture poses a direct risk to life science companies. And by understanding your culture and having a predictive diagnostic model that you can then do an assessment, see where your needed improvements are, target... Read more