Title: “The Emergence and Benefits of Cloud-based Digital Assays for Cell Culturing from a Compliance Perspective”
This talk focuses on CellPort Analytics™, a configurable, workflow-based SaaS laboratory execution system (LES) used for defining, executing and monitoring cell culturing operations. The key problems associated with cell culturing operations will be surveyed. Namely that manual cell handling and lab operations are a complex and highly variable undertaking, subject to a myriad uncontrolled forces that often undermine the quality of results. An overview of CellPort Analytics™ will be provided, with an emphasis on integrated support for both human-centered and autonomous (software agent) workflows that can be used at all stages of development (Research, Development & GLP and Commercial GMP). The benefits of managing assays as strategic digital assets will be highlighted: transparency, traceability, transferability and training. The compliance challenges unique to supporting such digital assays will be covered in terms of eSignature, deviations management, data integrity, scale-out, predictability, batch-record feeding, role-based security and public Cloud infrastructure and managed services.