Quartic.ai, provider of enterprise-grade industrial AI solutions to enable intelligent process manufacturing, announced last week the results of a survey which revealed that a majority of respondents are seeking validated cloud solutions to address GxP compliance, and computer system validation (CSV) and CFR21-11 requirements.
The survey was conducted during a recent webinar, “Validation of Cloud-based Manufacturing Data, Machine Learning, and Analytics for GxP Applications,” which showed that 79% of survey respondents expect to adopt a validated cloud in the next year. The webinar survey also found that validation has kept 63% of respondents from deploying operational analytics in the cloud.
Cloud and hybrid cloud-based operational data infrastructure, distributed computing, advanced analytics, and machine learning are providing unprecedented opportunities for advancement of product design and commercial manufacturer efficiencies in process industries.
However, common misconceptions about the application of cloud-first technologies to regulated industries are keeping teams from taking advantage of cloud-based systems. Complexity and time are also added to validation efforts if modern systems are built from scratch using managed services.
In the recent webinar, Quartic and GxP and FDA CSV expert John Hannon, from CAI, discussed how to overcome these challenges with a purpose-built, cloud-first technology stack. The discussion also covered how the two companies are working together to apply these validation protocols and best practices in GxP validation in a cloud environment to a large molecule continuous manufacturing process.
Over the last year, Quartic worked with CAI to create a validated cloud-based AI-driven solution for PD (process development), CMC (chemistry manufacturing and controls), PQ (process qualification), OQ (operational qualification) and semi-autonomous manufacturing of multiple molecules, for a joint customer’s autonomous continuous flow reactor. This reactor represents a real application demonstrating how organizations can apply cloud-based AI-driven analytics and controls in a validated environment, while conforming to regulatory requirements. Click here to watch Quartic.ai’s on-demand webinar in its entirety.
Quartic helps manufacturers predict and control the current and future state of their manufacturing operations to improve batch operations, decrease waste, reduce the need for quality checks, and deliver better product faster. Purpose-built for manufacturing engineers, reliability experts, and data scientists, the Quartic Platform is used by manufacturers to apply machine learning, analytics, and edge computing to solve very real challenges in their process manufacturing. By harnessing the power of data and AI, Quartic is making autonomous manufacturing a reality. For more information, contact Quartic.ai at 1-866-QUARTIC or visit www.Quartic.ai.