On Tuesday the 29th of March Odyssey VC hosted the first part of our 4-part 2022 webinar series “Possibilities and Practicalities of Cloud Adoption in Life Sciences”.
In Part 1, titled “How to build a successful regulated cloud adoption strategy”, we discussed why it’s important that a cloud digital vision and strategy must also incorporate a well-crafted compliance strategy. Throughout two presentations and a Panel Discussion we explored how regulated organisations can identify what regulatory requirements need to be considered and looked at practical steps to take to implement your cloud digital vision compliantly.
The webinar featured contributions from Odyssey VC CEO & Co-founder Oisín Curran, Head of Business Solutions and Co-founder Fionnán Friel, and Head of Customer Success Tom McKittrick, and was hosted and facilitated by Product Manager Pauline O’ Riordan.
Many fresh insights were shared during the session. Whether you were in attendance or not (you can receive videos of the entire event as well as news about Part 2 by registering here), here are four key takeaways from the webinar.
Partnering with competent vendors and designing for regulatory uncertainty is the key for Life Science companies
CEO Oisín Curran’s presentation, “Possibilities of cloud adoption in life sciences”, was full of insights, starting out with some key metrics to frame his discussion of the possibilities of cloud adoption. According to Forbes, only 44% of companies are prepared for potential digital disruption, while 60% of companies that have undergone a digital transformation have created new business models.
He pointed to regulatory uncertainty as a key factor driving adoption of next generation digital tools in Life Sciences. “You know that regulatory uncertainty is part of the business,” he said. “Looking to partner with competent vendors who are looking to solve these problems at the edge to help you get more agile, faster-to-market products … I think that’s going to be a critical part of success.”
You need to ensure your business and product is audit ready
For Software Companies and Connected Health companies, on the other hand, the key is aligning with the regulatory needs of Life Sciences companies. Oisín described this as a “market opportunity” for these companies, and it brought him to the subject of audits.
He pointed to EMA (European Medicines Agency) and their stance on XaaS; “Use of XaaS without the possibility to audit or ensure Annex 11 is fulfilled should not be accepted”. “You cannot accept a service unless you can demonstrate that Annex 11 has been fulfilled,” Oisín said, echoed by Fionnán in his presentation.
At Odyssey VC we can help your organisation to be audit-ready, both for customer and/or regulatory or notified body audits. Our audit teams include lead auditors (trained to ISO 19011, ISO 9001, ISO 27001 & ISO 13485) and audit team members with expertise in Quality Management Systems, Information Security, Software Development Lifecycle Management and Computerised System Lifecycle Management. Learn more here.
The regulators are encouraging cloud adoption and adapting accordingly
Head of Business Solutions and Co-founder of Odyssey VC Fionnán Friel covered “The practicalities of cloud adoption in life sciences” in his presentation.
One salient point highlighted by Fionnán; regulators are encouraging cloud adoption and going digital. Why? For a start, it makes their jobs easier. “It’s much easier for them to audit companies if the data is there in digital format,” he said.
As well as this, guidance is adapting to cater for it. In fact, it already has; GAMP already touches on Agile and iterative testing, and already they have “recognised the need to refine it to help companies go where they want to go”, with the pending 2nd edition set to further harmonise the relationship between GAMP5 and Computer Software Assurance (CSA).
You don’t (and should not) have to adapt your QMS to go digital
External suppliers need to fit within your existing QMS Framework. According to Fionnán, if questions are not satisfactorily answered and / or supporting documentation isn’t provided, you need to follow your standard supplier assessment process. Why change now? “People think it’s going to be a major shift, but it’s not,” he went on. “Your existing QMS should help you go digital in the current way that it is shaped.”
Part 1 of Possibilities and Practicalities of Cloud Adoption in Life Sciences took place on the 29th of March 2022. Part 2 will be announced soon. To watch the webinar and to receive exclusive news about Part 2, click here to register to our webinar series mailing list.
