Remote Authentication Device for Data Integrity
- Attributable – Biometric Identification establishes reliable and accurate operator identity associated with manufacturing activity.
- Legible – Delivers digital audit logs in a secure database available for reporting and analysis.
- Contemporaneous – Real-time logging and recording of operator activity on the shop floor.
- Original – No Paper, no copies, no modification possible in our Part 11, CFR 21 and EC Annex 11 compliant audit log records.
- Accurate – Iris Biometrics achieves 2.250 TRILLION to 1 accuracy in matching. Integral’s audit logs are 21 CFR Part 11 compliant and are fully verifiable and tamper-proofed.
More Info… (WHO Annex 5 – Guidance on good data and record management practices Appendix 1 – pg 192)
To Achieve Data Integrity in your operations, you must track operator activity in your supply chain.
With our Biometric Identification solutions, you can enable full traceability and accountability in activity logs.
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.
FDA expects that all data be reliable and accurate and comply with 21 CFR parts 210, 211, and 212.
EMA GMP guidance on Data Integrity is in alignment with FDA and emphasizes taking a risk based approach to data integrity.
Data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health.
Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.
IB RAD - LogBook
Mount the Integral Biometrics (IB) RAD with integrated Iris or Finger sensor to any manufacturing machine (no HMI or computer required) and associate it with our web provisioning tool to be able to identify machine operators and log their GxP related actions to a central DB audit log.
Say goodbye to paper logs.
IB RAD - I-VRK
The Integrated Virtual Remote Keyboard, hosted on the RAD, enables HMI logins without software installation or integration. Powered by USB, and wirelessly accessible, the IB RAD I-VRK types users’ credentials using simple login scripts into nearly any computing platform that recognizes a standard keyboard. Ask about our Bluetooth version!
Zero thin client? Can do!
IB RAD - Multi
Deploy numerous fingerprint sensors to any shop floor manufacturing equipment and enable full operator accountability with fingerprint biometric based identification and logging.
The Multi solution offers many flexible cost effective designs for deploying the LogBook functionality.