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Using PTC’s ThingWorx Solution in a GxP Regulated Environment

The Internet of Things (IoT) is used worldwide in many industrial environments.

IoT technology enables organizations to analyze and optimize business processes to obtain operational and productivity efficiencies. The use of IoT technology also provides a significant opportunity for life sciences companies to enhance their business processes.

However, since life science companies are heavily regulated, there has long been a belief that technological innovations would negatively impact regulatory compliance and create more substantial burdens in meeting computer system validation regulatory requirements. Hence pharmaceutical manufacturers have lagged in adopting new technologies that capitalize on the advantages IoT provides.

This white paper aims to dispel those beliefs and show that by embracing and adopting best practices in validation and risk management, life science companies can take advantage of modern technologies and IoT solutions to improve their business processes and drive innovation.

Further, this white paper describes how to validate PTC’s ThingWorx IoT platform solution in GxP regulated environments. Please note, while ThingWorx Industrial IoT Solutions Platform (IIoT) provides tools and technical solutions for complying with regulation, the regulated company or regulated user of ThingWorx must also provide controlled processes and procedures to fully comply with applicable regulations.

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