Risk considerations for the implementation of extended reality solutions within a GxP environment in the biopharma industry

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 solutions are often linked to home entertainment and the gaming industry; however, they are becoming more common in the workplace in various industries, including healthcare and biopharma. When implementing this technology in GxP environments, careful thought must be given to the risks associated with deployment.

This paper highlights the risk considerations in different categories based on the appetite of the organization for risk, local country laws, company policies, and IT hardware/software standards. It also includes risk/impact statements to provide context for the risks being considered. The risk considerations are not intended to replace traditional risk assessment but rather to support that process.

The paper aims to help deploy AR/VR technology in biopharma GxP environments. It also gives the areas of risk for IT professionals and users of these technologies at biopharma organizations to consider when developing the technology internally or implementing an off-the-shelf product.

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Risk considerations for the implementation of extended reality solutions within a GxP environment in the biopharma industry June 2023.pdf
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  • Create Date 30th June 2023
  • DOI https://doi.org/10.46220/2023IT004
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Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

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The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

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BioPhorum brings you the latest Deliverables Report, an informative and inspiring consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry user requirements, study results, and roadmaps produced in the last twelve months.
Technology Strategy
Buffer stock blending system
Knowledge management
Technology adoption
Operations
Change notification
Closure playbook
Extractables and leachables
In-Line Monitoring and Real-Time Release
Raw materials
Regulatory Governance and External Partners
Single-use systems
Annex 1
Information Technology
Digital integration of sponsor and contract organizations
Digital plant maturity model
IT for cell and gene therapies
Lab of the future
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