On Tuesday the 2nd of November Odyssey VC hosted the second part of our 4-part webinar series Compliant Digital Transformation for Life Sciences.
Part 3, titled “Why adopt cloud technology for your GxP applications?” discussed cloud technology adoption for GxP environments, addressing key questions such as:
• Are the benefits of cloud worth the investment for life sciences?
• Regulatory bodies are encouraging the development of GxP cloud applications but are they doing enough by way of guidance?
• What are the grey areas of cloud adoption for life sciences?
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 Nuala Calnan. The free event included an engaging panel discussion and presentations on topics such as getting vendor assessment right and the risks and benefits of adopting cloud technology for your GxP applications.
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.
Cloud solutions are a double-edged sword for QA
Our industry guest speaker for Part 3 was Nuala Calnan, Founder & Principal of BioPharm Excel. Nuala works with organisations to think creatively about achieving excellence-led solutions to the challenges involved in assuring the global supply of high-quality human drug, medical devices and diagnostic products.
She shared many insights in her presentation, titled “Understanding the risks and realising the benefits when adopting cloud technology for your GxP applications”, including this; cloud solutions are a double-edged sword for QA. That doesn’t mean we should “shy away”.
How can it be done properly? “You need to use a sound, risk-based approach, you have to document your justification and, furthermore,” she said, “you’ve got to build in ongoing sustainable practises whereby you’re continually checking the status of your data, the status of your version control”. She also said that you need to ensure that you’re “fully in the loop in terms of your supplier contracts and documentation.”
How do you apply effective risk management? Think of the end user.
Elsewhere in her presentation, Nuala stressed that to apply the fundamentals of effective risk management, “it is critical that you maintain a clear line of sight to the patient at all times”, including “recognising the impact that your actions can have on the long-term outcomes of the patient”.
She went on to say that “you’ve got to be looking at your technology platforms” as well as your end-to-end data lifecycles, recognising and addressing what the potential impact on the patient could be, considering everything from loss of data to cyber-security issues.
You can never outsource your responsibility
Odyssey VC’s own COO Fionnán Friel delivered a presentation titled “Assessing cloud vendors – get it right, keep it right”, building on Nuala’s presentation with practical tips and useful cautions.
While he was discussing the evolution of the use of cloud technology in the industry – including the pros and cons – Fionnán addressed the lingering question around whether there will be new regulations to cater. His answer, reflecting Nuala’s, was no; the same regulations apply, and expectations from regulators are the same.
Regulators still see it as an outsourced service which is no different, he said, to “getting someone to supply you with vials”. He went on to say that the regulated company is ultimately responsible for patient safety, product quality and data integrity – “you can never outsource your responsibility.”
Fionnán also dealt with questions that are critical to cloud adoption, including “should I apply a different type of assessment to a cloud provider?”. His answer was no; “follow your process. Expand your process with questions but fundamentally, you should execute it the same as you would for any vendor.”
Regulators support the adoption of cloud technology
During the panel discussion segment of the webinar, our panel – featuring Nuala Calnan, Oisín Curran, Fionnán Friel and Mag Corduff – were asked the question; how should industry leaders address the scepticism of and resistance to introducing new technologies like cloud in the Life Sciences sector?
Fionnán pointed to the recent good practise guide on data integrity, which encourages the use of modern technologies and modern software, just as the FDA encourages Computer Software Assurance and “new methods, new software, new technologies”. “The regulators are behind us”, he said.
Building on what Fionnán said, Nuala stressed the importance of use cases, especially post-pandemic and the “huge amount of pressure … not to step back into this ten-year lifecycle for products”; “don’t try to sell them the technology or the platform. Look at the use cases.” From R&D screening to clinical trials, she said, the adoption of digital technologies such as cloud “do enable us to make much much faster decisions”.
Part 3 of Compliant Digital Transformation for Life Sciences took place on the 2nd of November 2021. Part 4 will take place on Tuesday the 7th of December at 12:30pm GMT. To watch video of each presentation from the webinar and to receive exclusive news about Part 4, click here to register to our webinar series mailing list.