July 13, 2010QA Assistant today announced Validation Certificates are available for the upcoming QA Assistant Studio™ release. Our dFMEA, pFMEA, Control Plan, and Process Flow software will be independently validated to ensure we continue to provide the very best service in the industry to our customers.
The significance of independent validation
According to the Food and Drug Administration (FDA), 7.7% of the medical device recalls the FDA analyzed were attributable to software defects1. QA Assistant strives to deliver zero-defect software to enable our customers to focus on engineering tasks. We already perform thousands of functional tests before a product is released. QA Assistant™ is also ISO 27001 compliant so our code development practices are already first class.
In addition to our existing quality procedures, our software will now be independently verified against our software's functionality requirements, user requirements specification, test procedures, and functional testing checklists to ensure it meets the highest standard of performance and reliability. Our software validation procedures are in compliance with FDA requirements. Full validation reports and certificates will be available to our customers through each revision of the software.
Speaking at a meeting with our engineers yesterday, Brenda McGuinness, QA Assistant™ MD, commented "QA Assistant continuously takes steps to ensure delivery of our products meets the very highest in quality standards. Independent validation is the next step in continuing to provide services for our customers which build our relationships with them and differentiate us from our competitors." 1 FDA General Pricipals of Software Validation; Final Guidance for Industry and FDA Staff