Clinical Software Quality Assurance Drives Continuous Improvement


This presentation covers an important category of software testing: Clinical software quality assurance.

Clinical software testing is strictly related to compliance and conformance to standards. Given the mission critical nature of the such software applications, the impact on a patient’s life can be fatal. A defect in a software application that manages patients’ care can cause life threatening circumstances. This means that there is no room for error.

What are some of the strategies that can be adopted to prevent these failures? Unlike the financial sector applications where a defect may cause errors that affect dollar amounts, the defects discovered in the production environments of clinical software have a deeper impact on human lives. This topic covers how risk management, quality governance and continuous improvement is driven by “Clinical Software Quality Assurance.”

Learning Objectives:

  • The difference between clinical and non-clinical software QA processes
  • Risk assessment and mitigation techniques
  • Importance of continuous improvement and non-complacency when it comes to quality governance
  • Why engaging QA resources early in the process is crucial to the health of the software in test
  • Peer review is not an alternative but a necessity
  • Importance of regulatory requirements and guidance in this vertical
  • Necessity for vendor and subcontractor qualification audits
  • Why internal operations compliance including process audits are a must