Life Science companies tend to be very conservative. It’s no wonder, considering the heavily regulated nature of our industry. Often, we are late to reap the benefits of new technology, ideas and trends, far behind many other industries that react more quickly.
At Epista, we like to share our thoughts on important, and sometimes disruptive, industry trends we see coming our way. And to inspire you to use them - to turn your challenges into real business opportunities.
Trend Talks Season 1 focuses on the Life Science journey towards digitalization. Not just for business processes – also for support processes relating to quality. We're talking about fully digital, exception-based quality. Here’s our take on how to achieve this vision. We look forward to hearing your feedback. Enjoy!
The conservative Life Science industry is experiencing a paradigm shift with the much-talked-about change from CSV to CSA. There’s no doubt this shift will result in challenges for many companies.
Epista is a team of experts working at the intersection of business priorities and compliance requirements. Watch Trend Talks Episode 1 to hear from Klavs Esbjerg, Epista’s CEO. He shares his take on how you can reap the benefits of a business-critical, updated version of computer system validation – Computer Software Assurance (CSA).
Guidance from the FDA on CSA is on its way. And while this move from CSV to CSA will help to drive your company’s innovations more efficiently, it also creates a variety of new challenges. In the first Trend Talks episode, Klavs answers your questions about this change, including:
Moving to new ways of working within IT can create new risks to productivity and compliance. If you’re transitioning from CSV to CSA, we can help.
Congratulations, you’ve invested in a new, cloud-based system. What now?
Once you’ve implemented your cloud-based system, new compliance challenges can arise. From continuous, frequent updates to forced system releases, testing, re-validation of processes, and more, being compliant is something that needs to be skillfully managed.
How will you maintain the validated state of your cloud system? How will you ensure continuous improvement and compliance? In this episode of Trend Talks, we go deeper into the paradigm shift from CSV to CSA and discuss Test Automation – specifically, system testing and platform maintenance.
Do you need help to ensure that you are continuously improving and always compliant? Read about our Managed Operations services here.
Whether it’s the Cloud, CSA, or another technological advance, Life Science companies are moving toward full digitalization – for both business and quality support processes. The industry has been talking about this for a long time, yet we still haven’t achieved it. Why?
Digitalization is still a vision because our conservative industry has yet to widely adopt cloud solutions, but we need to make a change. By adopting new technologies, we would be able to improve efficiency with advancements such as validation dashboards that allow you to check your degree of compliance – quickly, every day.
With CSA, the FDA acknowledges that we need more critical thinking in our compliance efforts. Now, just add the technology for test automation and we’ve reached full, exception-based validation. Yet, there are significant risks when it comes to maintaining the validated state of these IT systems in the cloud. Especially since the authorities have, thus far, provided little guidance.
Watch the final episode of Trend Talks where Klavs combines the concepts from episodes 1 and 2 to help Life Science companies reach the full potential of digitalization, continue to innovate, and thus further contribute to society.
Want to know more about how to turn your compliance challenges into business opportunities? Learn more about our expertise.
We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.