Medical Device Qualified Supplier Directory


Guidelines for Storing and Protecting Electronic Records and Applying Electronic Signatures

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 new 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 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.

Using a leak tester like Uson’s SprintmD helps end users comply with 21 CFR Part 11. It’s important that the leak tester contain certain essential features required to support the compliance process, such as electronic signatures and an audit trail. Compliance with 21 CFR Part 11 is a shared responsibility, with specific areas only the end user can implement and enforce. These areas are identified in this white paper, but additional actions may be required that are not in the scope of this document.

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