Quality Management Software


Medgate’s Quality Management Software will transform how you manage your quality system. Achieve excellence by streamlining and integrating your processes. For three decades, Medgate has helped hundreds of manufacturers connect and empower their people with processes and technology across the value chain. The software provides an accessible, simple-to-use way to drive improvement without compromising the effective management of regulatory requirements, standards conformance and customer mandates. At its core, Medgate’s Quality Management Software (QMS) serves as the hub for everything related to quality system management. It delivers actionable insight into performance, cost of quality and risk-related metrics including real-time visibility on supplier quality, production and customer satisfaction. We understand that the quality management challenges you face are unique and require configurable solutions.

  • Easily track all nonconformances and CAPAs for compliance
  • Satisfy quality standards, such as ISO 9000, TS 16949, AS 9100, ISO 14000, ISO 13485, FDA GxP
  • Become more competitive and control the cost of quality
  • Manage your audits in one central tool to schedule and perform audit tasks including findings and CAPAs
  • Store all inspection data including revision levels and change histories
  • Track down to the individual employee or supplier who produced the nonconforming product
  • Gain visibility over your supply chain through our supplier portal with supplier issue tracking, audits, and scorecards
  • Reduce the headaches associated with changes to design requirements across multiple manufacturing sites and through your supply chain using Management of Change (MOC) / ECN
  • Foster communication and collaboration with your customers by ensuring that complaints are tracked and root cause analysis is conducted
  • Streamline document control from change requests to archiving, providing employees the ability to locate and execute document revisions quickly
  • Track equipment usage for traceability, accountability, and maintenance scheduling
  • Show the success of your training initiatives through a single interface that tracks all courses including those required by job position
  • Identify and manage critical points Utilize our FMEA / Control Plan / Process Flow Software to ensure your design processes are controlled
  • Avoid errors and inefficiencies with Statistical Process Control such as collecting data, defining sampling plans, accommodating new supplier performance data, integrating with legacy systems and creating SPC charts
  • Track your gauge calibration process such as RR ANOVA, RR attribute, RR range and stability/linearity studies to ensure gauge calibration
  • Create an enterprise-wide platform to manage all Production Part Approval Process (PPAP)/first article documentation via a single interface with an unlimited number of user-defined steps

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