On Tuesday the 28th of September Odyssey VC hosted the second part of our 4-part webinar series Compliant Digital Transformation for Life Sciences.
Part 2, titled “How can you satisfy ALCOA+ principles as part of your Compliant Digital Transformation?”, took a practical look at how to tackle digital compliance obligations, addressing key questions such as:
• What are the highest-level risk areas and main pitfalls?
• Does using smart digital solutions reduce your digital compliance obligations?
• Are there new risks and pitfalls to consider?
The webinar featured contributions from Odyssey VC’s own Oisín Curran, Fionnán Friel and Mag Corduff, as well as industry thought leader and guest speaker Dr. Joe Brady. The free event included an engaging panel discussion and presentations on topics such as understanding the basics of the ALCOA+ principles and designing for data integrity. Many fresh insights were shared during the session. Whether you were in attendance or not (you can receive videos of the entire event by registering here), here are four key takeaways from the webinar.
We need to be teaching ALCOA+ principles “very early on”
Dr. Joe Brady’s presentation was focused on understanding ALCOA+ principles, and he emphasised that earlier is better in terms of teaching ALCOA+ principles. This is reflected, he said, in how we teach kids in school and people in university how to be “neat and tidy” in presenting their data and reports for grading as part of an assignment submission, but “what we forget to teach them is integrity” and learning by “reverse-engineering your mistakes”.
If someone writes the date wrong, for example, we often have to fight the urge to quickly change that seven to an eight, even having been in the Life Sciences industry for years. This is why we need to be teaching people “very early on” in science classes, even as early as primary school, about ALCOA+ principles and that “each piece of data has to have integrity.”
Implementing a computerised system isn’t a fix-all
During the panel discussion, in answering the question “what gains are possible from an ALCOA+ perspective when moving from a paper-based manual system to a compliant digital system?”, Dr. Joe Brady gave this sage advice; ultimately, computer systems are tools – “they should not be an impediment to progress.” He went on to say that, if corporate introduce a computerised system it’s in the context of enhancing the business and “giving time back to some of the end users”.
However, he stressed that computerised systems aren’t cure-alls. “If the computerised system is cumbersome it’s just going to take even more time to train staff and manage upgrades,” he said. “If you find that everything is actually taking longer, you don’t have effective implementation of a computerised system.” Instead, he said it’s “how you implement, operate, maintain and upgrade” a computerised system that makes it effective.
Having integrity means being honest – both with yourself and with others
Dr. Joe Brady pointed to this year’s example of UK post offices using the application Horizon to illustrate what can happen when digital transformation goes awry. In this case, the Post Office prosecuted 736 employees between 2010 and 2014 for false accounting and theft based on flawed information provided by Horizon, which had been installed in 1999 and began reporting shortfalls, some of which amounting to thousands of pounds. This final quote is a pertinent summary; having integrity, when boiled down to its essence, means being honest with yourself and others.
“Yes, it might be the end user sitting in front of the FDA defending data integrity,” said Dr. Brady, “but if we’re going to help assist and digitally transforming their systems, remember; us as vendors and suppliers must also be aware of our data integrity requirements. We should be testing and testing and testing to make sure that whatever we digitally transform is accurate.”
Good Data Integrity means a bright future – which includes AI and Machine Learning
In his presentation “Data Integrity by Design”, Odyssey VC’s own COO Fionnán Friel built on the foundations Dr. Brady laid down with a fantastically detailed deep dive into designing for data integrity and building it into systems and processes from the start.
Reflecting what Dr. Brady said, he stressed that it’s critical that Data Integrity is maintained, “but also critical that it doesn’t become a barrier to compliant digital transformation strategies”.
In his closing notes he looked to the future, asserting that the advent of Data Integrity, Data Quality and Data Analytics has given scientists “the tools to work smarter and faster to improve the lives of patients”, and that even more opportunities for growth are presenting themselves.
Whereas previously Artificial Intelligence and Machine Learning were seen as “no-go areas” for processes as they were considered to be “too difficult to validate or use in Life Sciences”, now there is a section in the new guidance directing companies on how to use AI and Machine Learning the right way.
He called on everyone to “use the data we’re generating to its fullest extent” and not to shy away from using “the amazing power of computerised systems and software to build better outcomes for patients and companies within the prescribed and accepted framework”.
Part 2 of Compliant Digital Transformation for Life Sciences took place on the 28th of September 2021. Part 3 will take place on Tuesday the 2nd of November at 12:30pm GMT. To watch video of each presentation from the webinar and to receive exclusive news about Part 3, click here to register to our webinar series mailing list.
