21 CFR Part 11 regulates the use of electronic quality records and digital signatures. Along with EU GMP Annex 11, 21 CFR Part 11 compliance is required for manufacturers in pharmaceutical, life sciences and medical device industries. Nymi can assist with critical requirements of 21 CFR Part 11, including digital signatures, operational controls and security controls. Nymi, as a biometric authentication product, offers improved data integrity, reduces risk of compromised credentials and can add to improvements in user experience. NEE solution enables our customers to comply with regulations in a reliable and effective manner. The Nymi solution enables customers to comply with this requirement by replacing passwords or badges that can be compromised. The FDA noted that “… biometrics-based electronic signatures, by their nature, are less prone to be compromised than other methods such as identification codes and passwords.” (21 CFR Part 11) Through seamless integration, the Nymi Enterprise Edition (NEE) signals the system solution to record electronic signatures as outlined in 11.50. The NEE will maintain compliance for 11.10, such as limited system access, triggering the MES to record electronic signature for audit trails, and to “ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand”(FDA CFR Part 11). Through the implementation of technology, in addition to policies and procedures, the system will meet regulations and maintain a compliant ecosystem.

Nymi is a GAMP supplier, as outlined in GAMP5 guidance. As a supplier, we understand that our customers need to leverage supplier activities to the maximum possible extent and ensure fitness for intended use which is why Nymi, as outlined in the GAMP guidance, fully supports customers with GAMP Software Validation packages and supplier assessments. In order to support our customers, Nymi has implemented the following to meet our customer's needs: Map FS and CS to each customer specific User Requirement Specifications Provide samples and templates for GAMP documentation, including URS/FS/CS, as well as IQ/OQ/PQ documents Provide Test Reports that are available in a consumable format to our customers to prevent duplication of validation efforts Provide services related to validation activities to ensure a seamless validation process

When it comes to privacy and security, Nymi provides a Safe, Simple, and Secure workplace wearable, while protecting sensitive information and personal information. During user enrollment, fingerprint images are captured on the Nymi Band and converted into a fingerprint template - a subset of unique features found on the fingerprint. The original fingerprint images are discarded, never stored and never transmitted. To ensure your privacy is protected, the fingerprint template never leaves the Nymi Band’s microcontroller unit (MCU) and this information can be wiped at any time by the user. At Nymi, we ensure that the user has full control over their personal data, can provide consent and withdraw consent at any time.