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Non-Product Software Validation Consulting from Oriel STAT A MATRIX

FDA is cracking down on noncompliance for software applications used in the design and production of medical devices. Let Oriel STAT A MATRIX support your organization to understand what needs to be validated for intended use and how to meet US FDA and ISO requirements.


Does the software that you use in your day-to-day operations need to be validated for intended use?

Regulatory controls that ensure medical devices that roll off the production line will perform as intended extend to the software that is used in the production of your device (e.g. ERP systems) or to make quality decisions (e.g., Quality Management Systems) related to your device.

What Is Non-Product Software?

Non-product software (NPSW) is any software – home grown or off-the-shelf – used in the design, development, and production of medical devices and software tools used to implement the quality system itself. FDA  21 CFR 820.70(i) and ISO 13485 (sections 4.1.6: General Requirements, 6.3: Infrastructure, which now includes information systems, 7.5.6: Validation of processes for production and services, and 7.6: Control of Monitoring and Measuring Equipment). require that this software is validated for intended use. 

What Is Validation?

Validation is the process of evaluating and controlling both system and user requirements to ensure they meet their intended use.

How Can Oriel STAT A MATRIX Help?

Understanding what software needs to be validated for intended use, establishing a process for validation, and appropriately documenting it will ensure your organization meets US FDA and international requirements for non-product software validation.

Engage our experienced team to:

  • Educate your team on the process of conducting Non-Product Software Validation 
  • Conduct a Risk Assessment to determine if the system requires validation (following GAMP 5 or other appropriate risk assessment processes (e.g., ISO/TR 80002-2))
  • Develop a validation master plan outlining the scope, intended use, risks, and validation activities associated with the system implementation, testing, and acceptance
  • Guide the identification, documentation, and risk determination of user requirements, system requirements, functional specifications, and design specifications
  • Prepare Installation Qualification (IQ) protocols and test to ensure the IQ protocol requirements are met
  • Ensure Operational Qualification (OQ) protocols and tests align primarily to Functional Specifications and partly to User Requirements
  • Following User Acceptance Testing, ensure Performance Qualification (PQ) documentation appropriately aligns primarily to User Requirements and partly to Functional Specifications
  • Ensure appropriate change controls are in place that will prevent unintended changes from occurring with the software

Provided below are a variety of practice related white papers, market updates and case studies.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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