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This client had recently moved their quality system to the Greenlight Guru e QMS platform.Clients of Greenlight Guru are provided with a full validation package (IQ/OQ/PQ) to help them properly validate their system and show compliance to the new standard.Next, you should create a team to evaluate which pieces of software are being used in the quality system and evaluate the risk of each of those applicable pieces of software.This assessment can include Excel spreadsheets, databases, Solidworks/CAD files for design activities, issue tracking software, complaint management software or CRM systems, PLM systems, ERP systems, and/or distribution software programs.Achieving compliance will also include software maintenance and configuration management strategies from the beginning of the software lifecycle until its end.Last year, 79% of all software related FDA recalls were caused by software defects that were introduced to the system during changes made to the software after its initial production and distribution.Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software. As you read through this section of ISO 13416, there are a few details to focus your attention on.
This procedure will help guide your company to properly evaluating all QMS software throughout its lifecycle.
Medical Device expert specializing in development of efficient Quality Systems for small and startup medical device companies. Rose works as a the contract Quality Manager for multiple medical device companies overseeing overall quality strategy and ensuring compliance through documentation and auditing services. Rose is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets including FDA, CE Mark, Health Canada, and CFDA. Rose encourages the simplification of Quality Systems to reduce the quality burden and improve compliance through training and efficient QMS design.
At Minitab, we conduct extensive internal testing to maintain the highest quality of our software products.
When potential hazards are not properly identified, no control measures can be implemented to address and mitigate the potential risks.
The addition of certain tools into your quality system regarding software can help better identify commonly overlooked hazards.