Nymi™

Authenticator Device Solution for Increased Security Across Pharmaceutical Manufacturing

82 Peter St Unit 500, Toronto, ON, M5V 2G5, Canada



Nymi™ delivers a wearable, multi-factor authenticator device that improves security and regulatory compliance in pharmaceutical manufacturing environments.

The company’s enterprise solution combines biometrics with a durable workplace wearable to increase productivity, security, and health & safety challenges in one easy-to-deploy solution.

Wearable multi-factor authenticator device for pharmaceutical manufacturing facilities

Nymi’s biometric-based user-authentication workplace wearable, the Nymi Band™ addresses critical business needs for data integrity and productivity. It is designed to replace existing point-in-time authentication models, which are often used in manufacturing environments.

This innovative wearable device ensures that staff are continuously authenticated throughout their workday. This provides an enterprise and its regulators with genuine e-signatures to authenticate actions performed in production and laboratory settings. Multi-factor biometric authentication also ensures that each Nymi Band™ only works while on the wrist of an approved operator. Once authenticated, this cannot be transferred.

Wearable authenticator device for increased productivity

Operator logins and e-signatures are a significant area for productivity improvements. These time-consuming, repetitive actions not only hinder production but interrupt operator workflow. Nymi Band™ and the Nymi Enterprise Edition™ offers secure, wireless authentication to replace the need for passwords and paper signatures. Logins are replaced with a single action that takes a few seconds. This increases operator productivity, user satisfaction, and security.

The time saved by reducing login times and removing user authentication errors (failed usernames and passwords) leads to dramatic increases in efficiency for manufacturing environments.

Nymi Band™ users have continuous authentication that is fully functional when wearing gloves, cleanroom garments, or clean suits. It provides seamless interaction with manufacturing execution systems (MES) and general operator satisfaction.

Manufacturing staff authentication using biometric modalities

The Nymi Band™ is designed to increase a company’s security, authenticating single assigned users based on a variety of biometric sensors. Authentication is only required once at the beginning of a shift, completes in a matter of seconds, and persists until the operator removes the Nymi Band™.

Designed to meet security and privacy requirements, the user’s biometric information is only stored locally on the band and not on a server or Cloud. Nymi’s secure, independently reviewed architecture and hardware ensures tamper-resistant cryptographic operations that protect confidential data and certificates.

Nymi ensures the integrity of data through a combination of biometrics, on-body detection, and strong industry-standard cryptography.

Multi-factor authentication for increased security in pharmaceutical manufacturing

Nymi’s authentication technologies help pharmaceutical manufacturers to increase security and improve compliance with international regulatory requirements.

Only specific employees can perform certain tasks, at the required times and for the right reasons. By offering improved data integrity and a reduced risk of compromised credentials, Nymi™ can assist with critical requirements of

the US Food and Drug Administration (FDA) 21 CFR Part 11 and EU GMP Annex 11. Through the implementation of technology, in addition to policies and procedures, the system will meet regulations and maintain a compliant ecosystem.

Nymi™ also provides real-time, on-demand traceability and secure electronic records, allowing for simpler and less intrusive audits.

Innovative digital security solution for MES

Nymi™ understands that manufacturing environments require massive investment, so its products support the move to digitisation and reduce friction in the use of MES. Nymi Enterprise Edition™ seamlessly integrates with existing enterprise IT, ERP, SSO and identity management solutions for ease of deployment with minimal changes to IT and operational environments.

The company’s security architecture can be integrated with MES in highly regulated production industries to remove the burden of authentication from the user, while increasing accountability and eliminating failed logins.

Nymi™ has developed partnerships with industry leaders such as Evidian and Werum, allowing Nymi™ to access multiple software systems with a single login and with no custom integration required.

Enterprise architecture for secure communication

The architecture of the Nymi™ Solution comprises several components that ensure functionality, security and ease-of-use.

The Nymi Band is a workplace wearable that combines strong biometrics with presence-aware technologies to enable users to move through their physical workspaces and perform functions with security and ease.

A Nymi-Enabled Application (NEA) can be any web or native application that makes use of the Nymi Bands’ security functions. It allows for the integration of Nymi Band™ functions into common enterprise software, or virtually any relying party.

Nymi Lynk is a personal smartphone app that provides a Nymi Band user with full control over their identity and privacy. It enforces transparency in enterprise privacy policies and allows rich interaction with visualizations of your personal data and other useful tools.

The Nymi Enterprise Server™ is a database and collection of services that allow secure communication between bands, shop floor terminals and backend enterprise software such as single sign-on (SSO), MES and active director (AD) while managing certificates. It also includes an administrator console, allowing IT administrators to manage individual users, Nymi Bands, and policies. All of this is confidential, and the information remains proprietary to you.

About Nymi™

Nymi™ was founded in 2011 following the publication of research conducted at the University of Toronto that focused on the unique properties of electrocardiograms (ECG).

Nymi™ initially focused on licensing the ECG recognition software to third parties and original equipment manufacturers (OEM) to replace passwords. However, the team identified a new on-body authentication model, which had the potential to replace existing tools.

To bring this new concept to market, Nymi™ developed dedicated authentication hardware that became a foundation for the Nymi Band™ and Nymi Enterprise Edition™, which addresses niche issues in pharmaceutical manufacturing.

As the march towards Industry 4.0 continues, and the Industrial Internet of Things sees more and more connected devices on the shop floor, the need for secure authentication is becoming greater and greater. Nymi™’s involvement with nine out of the top ten global pharmaceutical companies has provided it with deep subject matter expertise, so that the firm was able to engineer a unique solution to real world enterprise challenges.

Nymi is made to deliver on the security and compliance mandate that the company’s customers face every day. It is proven to lead to productivity improvements and enhanced security, as well as meets compliance requirements in pharmaceutical production.

Nymi Band – Product Overview

Nymi band is a workplace wearable that enables employees and processes to stay safe and secure; the product is handsfree and straightforward to operate.

Solution Overview

Healthcare industries struggle to deliver the advantages of digital transformation (DX), as commonplace solutions entail trade-offs between security, compliance, and operator complacency.

Quality Statement

Nymi executed a Quality Management System (QMS) that aligns with its consumer demands and leads the development of products and solutions following GAMP5 (Good Automated Manufacturing Practice) guidelines by studying the pharmaceutical manufacturing process in its entirety.

Technology Partners

Developed to nurture an ecosystem that digitises the workforce, Nymi unites a complete set of benefits aimed at onboarding teams quickly through the Nymi Technology Partner Program.

Smart Building

Implement social distancing policies with real-time feedback to ensure the health and safety of workers, and analyse logs to identify high-risk behaviours.

Social Distancing and Contact Tracing

In addition to offering the most secure and simple solution for accessing doors, elevators, systems, and applications, the Nymi Band also determines the proximity of other Nymi Bands.

Developing a Connected Worker Roadmap

Nymi sees a world where workers are seamlessly integrated with Industry 4.0 practices. The Connected Worker is a human-centric approach to digital transformation (DX) that holds worker privacy, job satisfaction, health, and security at the forefront.

Nymi Solution Brief

Manufacturing, service, defence, and healthcare industries struggle to achieve the benefits of digital transformation (DX) in part because it is difficult to integrate their active workers with digital systems.

Mind the Gap: Security and Privacy Webinar

Today’s Pharma employee is highly trained, experienced and outfitted with innovative tools to imagine, strategise and manufacture tomorrow’s solutions. However, they’re hindered by yesterday’s infrastructure.

Xyntek Partners with Nymi for Wearable Biometric Devices

Xyntek Incorporated, a world leader in pharmaceutical and life sciences automation and IT solutions, has signed a partnership agreement with Nymi to increase their Turnkey Biometrics Authentication Platform to incorporate wearable technology.

Nymi to Host ‘Delivering Business Value from Biometric Security’ Webinar

The demand for increased pharmaceutical manufacturing is only offset by the growing stringent requirements by regulatory bodies for good governance over the manufacturing process. Warning letters for data integrity issues have more than doubled in the last couple of years. The need for trackability and traceability is at an all-time high.

Digitalising Pharma Manufacturing

A fully digital and smart workplace offers many benefits, including lower costs, improved quality, and higher productivity. Nearly everyone agrees about that. Yet in pharmaceutical manufacturing, the pace of change has been slow.

Authentication Solution Improves Data Integrity For Manufacturing Environments

Highly regulated manufacturing operations must control access to devices, applications and physical spaces to ensure data integrity, compliance and security without compromising productivity. Nymi is bringing a new innovative authentication solution to these operations with the Nymi Enterprise Edition.

Nymi Inc.