My fellow PowerPoint jockies, we have been outdone by ROCHE LIMIT, a surrealist point and click horror adventure that was created (and is played in) Microsoft PowerPoint.
The current build of ROCHE LIMIT takes around 20 minutes to play through and features one of the multiple planned endings to the full game. The actual narrative is quite Lynchian and appears to revolve around you accepting your (and possibly the human race’s) inevitable demise and a higher power’s ambivalence towards it. It’s a fun, quick little game, with excellent audio design and pixel art animation throughout.
Our PowerPoint presentations have a new standard, and that standard is this wild little game.
Anyone familiar with Annex 11 of Eudralex Annex 4 won’t be surprised by the content, but frankly I expect a lot of folks who have primarily experience on the clinical side will be scratching their heads. The fact that the authors felt the need to have an entire paragraph dedicated to unique user names is telling.
This is a great resource for sponsors who need to figure out just what to evaluate at investigators sites, a requirement this guideline repeats multiple times.
I’ll be very curious how effective sponsors are in ensuring this requirement is met “The investigator should receive an introduction on how to navigate the audit trail of their own data in order to be able to review changes.”
For a lot of reasons paper (and paper-on-glass) documents are with us for a long time. So it continually surprises me when I see documents in some basic, reduced readability font .
Even when we go to electronic systems that choice of font is going to be an important one. And it’s probably not the same font as what worked for you in a paper world.
And then there is all that training material and presentations (including conference material).
So spend some time and choose the fonts that works for you and your users. But please for goodness sake don’t default to a font because it is what you have always used.
I’ve recently seen a few audits that point out something along the line of “Recommendation to revise Quality Risk Management Process/Procedure to include detectability as a variable in determining Risk Priority Numbers (RPNs). The current process only includes the frequency and severity of impact in the calculation. However, ICH Q9 also recognizes the use of risk management tools which include the ability to detect harm (detectability) in the estimation of risk (refer to the section titled “Risk analysis”).”
So, first of all, that’s not what Q9 says. Q9 (R1) is actually pretty clear here, stating “Risk analysis is the estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the likelihood of occurrence and severity of harms. In some risk management tools, the ability to detect the harm (detectability) also factors in the estimation of risk.”
Q9 later goes on to state “Quality risk management supports a scientific and practical approach to decision-making. It provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity and sometimes detectability of the risk.”
Q9 clearly recognizes that detectability is useful sometimes, with specific tools in specific cases. This is in alignment with risk management thinking in general, for example ISO 31000:2018 states that Risk analysis should consider factors such as:
— the likelihood of events and consequences; — the nature and magnitude of consequences; — complexity and connectivity; — time-related factors and volatility; — the effectiveness of existing controls; — sensitivity and confidence levels.
Detectability is then one of several methods to consider in risk analysis. The selection criteria for tools should take into account situations when detectability is desired and drive to use of those tools, for example, the FMEA which is built to determine how and when a failure can be detected. In other tools, detectability is usually built into the evaluation of current controls and is often captured in likelihood or somewhere else
When it comes to risk, avoid a one-size fits all. Think of what the intent is and use the right tool for the job.
Yesterday the Food, Drug, and Cosmetic Division of the ASQ hosted a poster session on the question “What are you proud of in your eQMS? What about your implementation or continued use stands out and that you want to share?”
This was our first try and it also happened in one of the few winter weather events we’ve had this season in Boston, but I was incredibly pleased by the turnout and the five posters were all superlative.
I was actually so busy that the only photo I remembered to take was this one, which was actually 10 minutes before our official start time.
Electronic Forms – utilizing templates, tokens, and connectivity (Greg Greene, Amylyx Pharmaceuticals)
I thought each of the posters brought a different bit to the conversation, and wow were there a lot of conversations going on!
I definitely learned that next time I need to get recorded talks from folks. I had originally planned this, but it didn’t happen mostly because I was just too involved in talking about my poster.
I want to say an immense thank you to our very gracious hosts Veeva Systems, who provided a great spot and a whole lot of hospitality. Will Gould was great to work with and really went above-and-beyond as a host.
With the great attendance and the on-the-site feedback, definitely planning on doing this again. A quick survey to gauge interest and help select a topic is here: https://forms.office.com/r/rUf7VRE6Dy
Investigations of a Dog 