A medical device manufacturing client contracted Performance Validation (PV) to assist with creating a Computer System Validation (CSV) package for Microsoft R. Finding evidence of other organizations validating R for GXP compliance did not prove fruitful. Microsoft R is a free, open source application which uses the S language in statistical methodology. (https://mran.microsoft.com/documents/what-is-r) The software can handle very large data sets which was important along with functionality which allows the analysis to “learn” over time. Validation was needed since the calculations performed could improve patient care and reduce issues and failures with medical device operation.
The client was using R for a variety of statistical (linear and nonlinear modelling, classical statistical tests, time-series analysis, classification, predictive analysis, clustering, etc.) and graphical techniques. The client chose this software for its variety of proven packages and its ease and speed of processing. The client did not have a great deal of validation experience or manpower to write documentation, so PV was given a chance to help. The client requested PV write a Testing Plan, User Requirements, Functional Specifications, Installation Qualifications, Test Scripts, Traceability Matrix, and a Summary Report.
The following validation project considerations were identified for the client:
The PV team on this project leveraged years of experience in GxP compliance creating CSV packages for large scale software applications, and direct experience in compliance with the specific client’s procedures. This aided in the development of validation plans and consultation on the approach toward functional and user requirements. PV worked on site, collaborating with the client’s team members to ensure successful completion of the project within the established timeline. The PV solution was comprised of the following:
The validation was completed ahead of schedule, meeting the customer’s overall system implementation deadlines. The testing results were examined/verified by an independent reviewer and all discrepancies discovered were addressed. The business process and related regulatory requirements were equally emphasized and consistently met the client’s needs. PV provided regular project status updates which provided details on the project deliverables, project budget, and risks to the project and schedule.
This validation project gave the client a tool they could use to help determine probable service intervals minimize patient risk. They can rest assured their version of Microsoft R does not get automatically updated/changed. If they need to add another package, a procedure is now in place to guide them, or they can contact PV to support their needs.
The PV Advantage
Performance Validation provided the client validation project planning and execution for their stakeholder’s needs, and the best approach for validating an open source configurable application. The validation documentation focused on properly addressing regulations and internal procedures while working with Statistics experts, Project management, Information Technology, Quality Assurance, Subject Matter Expert, and the Application owner to ensure the success of the project.
Performance Validation was able to tackle a complex validation by offering suggestions, working with multiple divisions of the team, and adhering to a clients’ detailed documentation structure. PV was able to work on core documents while waiting for windows of time with the client’s Subject Matter Experts to maintain a constant rate of progress. Implementation of the validated software system allows the corporation to rely on Microsoft R for providing predictive service analysis.
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CSV Services Manager