Mikael Yde

Inspection Readiness in the IT Organization

What challenges does an IT organization face in inspection readiness? Mikael Yde speaks on best practices to prepare for an inspection from authorities

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One of the major challenges facing the Life Science industry today is the shift from the traditional system-centric IT approach to a data-centric one. This shift arises from regulatory pressures such as IDMP, UDI, GDPR and others, as well as the real business advantages derived from sharing data in different formats across multiple systems and platforms. It is a new way of operating, and puts compliance in the spotlight in terms of regulations, guidance, as well as solutions provided by vendors.

Mikael Yde, IT Compliance Officer at Radiometer Medical, presented his insight at 2016 Knowledge and Network Day as part of the Medical Device track. He provided an expert perspective on the challenges and strategies of preparing for inspection. 

According to Mikael: Compliance is not only about fulfilling requirements, but it is a cultural shift in an organization. In general, it is about knowing where you are and where you need to go — in other words, having a holistic strategy across departments. Creating a compliance plan signals to inspection authorities that, while there may be initiatives that need to be addressed, your company has a plan in place to handle them.

Watch this short video clip where Mikael outlines the challenges and best strategy for an IT organization. If you want to dive deeper, view his full presentation from Knowledge & Network Day, where he outlines how to define the right scope and how to create and implement an IT Compliance plan.


About Epista Life Science:

We're a consultancy dedicated to continuously improving regulatory compliance - for our clients and the industry. We pioneer new technologies and methodologies, and bridge the gap between QA, RA and Line of Business. Our goal is to influence the industry and contribute to a higher level of insight and maturity across regulators, technology suppliers and Life Science companies. It's an ambitious goal, and this event is one of the ways we aim to achieve it. 

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