FDA 21 CFR Part 11 compliance is mandatory for medical device and pharmaceutical companies that supply products into the United States. Part 11 is focused around electronic data management and electronic signatures. All mechanical testing data should be managed in a way to ensure that it follows the ALCOA acronym: the data is attributable, legible, contemporaneous, original, and accurate.
For medical device and pharmaceutical companies, achieving data compliance is best met through collaboration between the end users and the equipment supplier. The end users know how the equipment needs to fit into their quality management systems (QMS), and the equipment supplier knows how the system functions and how it can technically meet compliance requirements. In order to achieve full compliance there must be a partnership between the technical functionality of the system and the end user’s QMS. This article will summarize the requirements of FDA 21 CFR Part 11 and discusses the challenges and options laboratories face when transitioning from paper records to electronic records retention.