Extended reality (XR) is a term used to encompass different types of immersive technologies that integrate both digital and physical environments. It includes augmented reality (AR), virtual reality (VR), and mixed reality (MR).
XR applications are often linked to home entertainment and gaming but are becoming more common in various industries, including healthcare and biopharma. This is especially so since our industry is on a journey to increase and improve its digitization, e.g., in training, lab spaces, and manufacturing.
However, when implementing this technology in GxP environments, the risks associated with deployment must be carefully thought through.
This focus on risks is why we have written AR-VR: Risk considerations for the implementation of extended reality solutions within a GxP environment in the biopharma industry.
Get set up for success
“Augmented reality has the potential to transform the pharma industry and add tremendous value to the shop floor,” said Georgios Chantziaras, Senior Associate – Smart Factory Technology at Pfizer. “But we need to make sure we are set up for success by taking into consideration all the risks that come with emerging technologies.”
Our paper gives you risk considerations in different categories based on your organization’s appetite for risk, local country laws, company policies, and IT hardware/software standards. These cover regulatory, business, technology, and safety, health, and environmental risks. We do not cover every risk in each scenario, but we help define the types of risks that should be taken into account.
For each category, risk/impact statements provide context for the risks you should look at – these are not intended to replace traditional risk assessment but to support that process.
The statements are followed by questions that readers can use to guide risk discussions in that category. For example, under ‘regulatory risk’, questions include, what is and what is not considered GxP data in the system? And how will data integrity be maintained for GxP records?
The paper’s target audience is not just IT groups but also the teams that will be using this new technology – and those who are being asked to sign-off any investment. While AR/VR implementations are often seen as IT projects, business and technology risks are covered because collaboration with the business teams impacted by the new technology is essential. It will help them review the crucial issues when developing the technology internally or implementing an off-the-shelf product.
“To capture the value of these recent technologies, the industry needs to understand them and their associated risks,” said Jonathan MacDonnell, Director Digital Transformation – Group Operations at Lonza. “This paper brings together the pioneering AR/VR experiences of leading biotech companies and will help guide further investment decisions for AR/VR in our regulated industry.”
For more information, download the paper here . If you have any real-life experiences of implementing XR technologies in your business and would like to share them, please get in touch with Steve Zartarian, Global Change Facilitator, at firstname.lastname@example.org