Xyntek provides manufacturing, development, and enterprise-wide staff user authentication and/or electronic signatures through the use of biometrics. Any combination of password, identification card, or biometrics may be used for secure computer access and/or electronic authorization and signing. The Xyntek solution is based upon globally supported ID Center Software.
Xyntek provides IT integration and support to implement the solution across business-critical data management systems and existing legacy software applications throughout the pharmaceutical enterprise for Electronic Signatures. Applications that support Discovery, Development, Clinical Trials, Manufacturing, and Release within Pharmaceutical, Biotech, and Medical Device companies are supported, including popular Electronic Laboratory Notebooks (ELN) and Manufacturing Execution Systems (MES).
Biometric User Acceptance
Compliance, Audit and AccountabilityTo comply with regulations such as the FDA, you need the latest technology so you can prevent fraud whilereducing costs incurred from paper processes. The Xyntek Biometric Solution complies with FDA regulations(such as 21 CFR, part 11).
US Department of Health and Human ServicesHIPAA - Health Insurance Portability and Accountability Act, USA 2003
Procedures should clearly identify employees or classes of employees who will have access to protected health information (PHI).
Access to PHI in all forms must be restricted to only those employees who have a need for it to complete their job function.
U.S. Food and Drug AdministrationFDA CFR21 Part 11
Pharmaceutical industry, electronic books & records.
Electronic signatures must not be created until the identity of an individual is verified.
Convenient, secure, efficient - ID Center recognizes a person’s identity within seconds via their fingerprint, palm vein or iris pattern.ID Center provides the reliable basis for determining who gets access to any number of software applications and data. ID Centeralso supports strong authentication by means of smart cards or one-time passwords (OTP). ID Center significantly reduces the volume of help desk calls and ensures compliance with governmental regulations (HIPAA, FDA, SOX, etc.) and data protection law. Unsafe or complex passwords are now a thing of the past!
The Iris biometric hardware provides highly accurate, non-contact identification by the iris of the eye from 14 inches away while delivering security, convenience, privacy and productivity to millions of people around the world. Every iris pattern is unique and stable for life and since there are more readily measurable characteristics in the iris, iris recognition is regarded to be the mostaccurate, fastest, and scalable option for both small and large scale biometric deployments.
The Biometric Mouse allows users to log on to their PC or laptop using just their fingerprint as identification. This mouse incorporates biometric technology, thereby eliminating the need to recall difficult user IDs and/or passwords and still securing the system from unauthorized users.
Placed on top of the device, the biometric sensor will read each user's fingerprint and then match it to the fingertip identification records stored on the mouse itself. This provides a much greater level of security than matching to records stored on the PC, as hackers cannot access the templates on the mouse.
The Palm Vein hardware detects the unique vein patterns found under the skin of people’s palms. The PalmSecure sensor is a contactless device. It emits a near-infrared beam towards the palm of the hand. The deoxidized hemoglobin in the blood flowing back to the heart through the veins absorbs the infrared rays, causing the veins to appear as a black pattern. This pattern is recorded by the sensor and stored in encrypted form.
LIFE SCIENCESManufacturing Systems Solutions
Electronic Batch Record (EBR) Systems help pharmaceutical companies meet the critical challenges of increasing productivitywhile maintaining compliance levels required by the FDA in the new “Risk based approach to the GMP’s for the 21st century.” EBR’s free operators, supervisors, managers and quality assurance analysts from devoting large amounts of time consumed by manual activities that are done to ensure that batch records are filled in completely and correctly. By automating these labor intensive activities, savings of 50% or more are realized, primarily in areas of data capture, document preparation, and review.
Laboratory Systems Solutions
In the discovery phase for a new drug, scientists perform experiments to identify new compounds or therapies. Historically, they recorded their experiments in a paper lab notebook, signed the experiments, and met with another scientist who witnessedthe experiment. Eventually, the scientist provided the completed paper notebook to a Records Management organization forarchiving. Signing and witnessing is important, since it provides the date-time stamp for when a new compound was discovered. The date time stamp can be vital many years later when the company defends the patent for the drug. Converting this series of activities to an electronic lab notebook has been a dream for many years. Each step of the process that involves paper takes the scientist away from the lab, and reduces the time actually spent on science. Electronic signatures via biometrics from Xyntek can provide many benefits to the scientist in this process.
HEALTHCAREStaff Authentication Solutions
Access to Resources