Biometric fingerprint recognition aids 21CFR 11

Published: 1-May-2005


An 'out-of-the-box' product combining industrial automation with high-security biometric fingerprint operator recognition is being launched by UK company AJM Automation.

The new approach allows a scan of the live tissue in the pad of the operator's forefinger to be used in place of a user name and password as an electronic signature, making product or process contamination, whether accidental or malicious, virtually impossible, and ensuring batch traceability. A digital code represents each complete and unique fingerprint, and if no match is found, access is denied and an alarm protocol enacted.

Compliant with the requirements of 21CFR part 11, the HPX 15 XP series of HMI workstations come with a stainless steel front bezel to meet pharmaceutical hygiene standards and contain a customised PX15 touch screen PowerStation with CTC Parker's InteractX software for biometric security, and DataTrak software from Ultima Control Systems.

'The benefits of the system to the pharmaceutical industry will be its performance, speed and longevity,' said Andy Markgraf of AJM Automation. 'It is easy for a username and password to fall into the wrong hands. This system enables higher levels of security.'

The system can run in biometric mode, non-biometric mode (i.e. PIN number or password), or a combination of the two. 'This rugged technology is foolproof,' added Gareth Cole, of Ultima Control Systems. 'It's no different to signing a batch sheet at the end of the production process and actually makes the operator's life simpler.'

Up to 100 operators can be registered, and though the system is still being tested, Ultima believes there is only a one in 1.5 million chance of wrong identification.

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