Nymi discusses meeting FDA eSignature requirements with biometrics
Authentication wearable provider Nymi has published a three-part blog on the value of electronic signatures based on biometrics to pharmaceutical manufacturers, not only for compliance with FDA regulations but also for improved data integrity and user productivity.
The blog series, titled “Why FDA Title 21 CFR Part 11 matters more than ever,” starts with a history of the 20-year old rule, which sets out guidelines for keeping electronic records of Good Manufacturing Practices (GMP), replacing a patchwork of systems that Nymi says created inefficiencies throughout the manufacturing process and supply chain. A series of updates culminated in a final version of the guidance for computerized systems in clinical investigations being issued in 2007, providing clarity for the use of Electronic Records Electronic Signatures (ERES).
The second post explains Title 21 CFR Part 11 compliance, and the business ramifications for manufacturer’s systems. Companies are required to certify their use of electronic signatures as a legally binding equivalent of handwritten signatures with the FDA, validate software, and provide audit trails, among other measures.
The series concludes with an explanation of how biometrics, and in particular the Nymi Band, meet the requirements for digital signatures outlined in subpart C of the regulation. Those requirements include that electronic signatures are unique to each person and cannot be reused or reassigned to others, and that those based on biometrics can only be used by the individual they are assigned to. The Nymi Band stores biometric data locally, on the device, and features on-body detection, ensuring that it meets that compliance requirements, according to the company. It also provides records of every time intent is registered by “tapping” the band or bringing it within 3 cm of an NFC reader.
The blog touts Title 21 CFR Part 11 as providing a way for manufacturers to modernize processes, and biometrics-based signatures as a way to maintain compliance with the rule, while eliminating inefficient manufacturing management processes and ensuring data integrity.