US FDA guidelines for storing and protecting electronic records—known as 21 CFR Part 11—have been in place for more than 20 years. However, due to advancements in technology and innovation, combined with the sheer volume of data being generated, the regulation has never been as relevant as it is today for medical device manufacturers. This regulation includes the US Federal guidelines for storing and protecting electronic records and applying electronic signatures. The intent of these guidelines is to ensure that applicable electronic records are reliable, authentic, and maintained with high integrity.
Uson’s white paper, “FDA 21 CFR Part 11 for Medical Device Leak Testing,” provides a discussion of how the features and functionality of leak tester software can help to enable customers to meet the guidelines of 21 CFR Part 11.
Using a leak tester that supports compliance with 21 CFR Part 11 , such as the Sprint mD and Optima vT leak testers, makes it possible for medical device manufacturers to move new products into manufacturing quickly, and support the instrument qualification and operational qualification (IQ/OQ) processes with greater efficiency.
To obtain a copy of this whitepaper, simply complete the contact form on this page and a download link will be emailed to you.