AssurX

AssurX is a software platform that automates quality and compliance work, covering workflow, risk control and operations in one system. Customers can start with the functions they need and add others later.

What AssurX offers

• Corrective and preventive action — tracking of problems and their fixes.
• Complaint handling — including FDA eMDR and EU MDR submissions for medical devices.
• Document and change control — managed documents and approved changes.
• Audit, calibration and supplier quality — modules for audits, instruments and suppliers.
• Training, risk and compliance management — plus quality management review and manufacturing quality.
• Services — implementation, integration, data migration, validation, training and technical support.

Who it works with

Industries named include life sciences, medical devices and diagnostics, high tech and electronics, food and beverage, and energy and utilities. One customer quote describes a rollout in eight countries and five languages.

Key facts

• Delivery: AssurX Cloud QMS is available
• Industries: energy, life sciences, medical device, food and beverage, high tech