QEdge is automation enabled and AI infused enterprise wide closed loop, cloud friendly, risk based quality management software system that instills quality as a habit across daily business processes/operation, which helps improve product quality and ensures regulatory compliance. It is a highend configurable end-point solution where layouts, fields and workflows can be adjusted to follow organization structure. QEdge on cloud stays up to date with changing regulatory standards and is audited at our clients by various agencies: US FDA, UK MHRA, ANVISA, Health Canada and many others.
Integrated architecture within QEdge b/w quality events, document control & training solution brings a seamless experience for users and reduces potential inefficiencies that could result from unanticipated operational disruptions.
Distinctive solution:
:: Quality Events (Change control, Deviation, Investigation, CAPA, Market complaint & many such events)
:: AI enabled digitization of quality events with controlled record keeping
:: Doc Control (SOP, Specifications, Work Instruction, and many such related document types)
:: Securely collaborate, version and distribute documents with cross geography teams/departments
:: Training (Employee dossiers, training planner, training execution & records with assessment)
:: PQR
:: Our automation process intends to establish automated interface with SAP, LIMS, eBMR and eQMS to produce almost ready to be consumed PQR document template based on pre-defined quarterly molecule schedule
Distinctive capabilities:
:: Automated workflows
:: Smart notification engine
:: Role based accessibility
:: Smart search
:: Dynamic report builder, Dashboard
:: AD based identity management
:: User check-in check-out
:: User; record & field based audit trail
With consumer grade UI, QEdge is successfully adopted across 30+ regulatory approved sites and enjoys 4000+ users spread in 15+ countries.