Editor’s Note: A White Paper on “Securing the Manufacturing Environment Using Biometrics”, by Purdue University professors Shimon Modi and Stephen Elliott, is available at the following link: www.pharmamanufacturing.com/
The use of biometrics becomes more prevalent in pharmaceutical environments — encouraged by the stipulations of 21 CFR Part 11. As in other industrial settings, technologies and standards continue to be developed and honed. Viable vendor solutions and standards exist for fingerprint recognition (both for “minutiae” and “pattern” recognition), facial recognition, iris recognition and hand geometry.
Fingerprint recognition is the oldest, most common and, because of economies of scale, the cheapest biometric solution available, says Dr. Shimon Modi, director of research at the Biometric Standards, Performance and Assurance Laboratory at Purdue University’s Department of Industrial Technology. In pharmaceutical sterile environments, where operators are gloved, facial and iris recognition systems are becoming more common, he says. Multifactorial authentication solutions — such as those combining biometrics, radio frequency identification (RFID), password protection and other measures — are also gaining in popularity, especially as U.S. government federal information processing standards (FIPS 201) have been mandated.
As biometrics vendor providers proliferate, interoperability has become a critical issue. One vendor’s fingerprint data structure may not equate with another’s, an important consideration as manufacturers implement biometric security solutions worldwide and develop central depositories of employee information. “What happens if you have an individual based at a U.S. facility and he goes to China and tries to enter a facility there?” wonders Modi. It’s not a major issue at present, but one that manufacturers must anticipate.
There is no one-size-fits-all solution, Modi says. He offers up three main suggestions for manufacturers beginning or rethinking their biometric security systems:
- Make sure that whatever system and devices you use are standards compliant. This protects the manufacturer from being stuck with inoperable systems if a vendor goes out of business or if its technology becomes obsolete.
- Try to use biometric sensors that are of the same technology type — that is, if you’re using optical sensors within one facility, it’s a good idea to use them at other facilities as well. Modi also recommends that manufacturers rely upon a single vendor — while standards are progressing, interoperability between different vendors of similar technologies can still be a detriment to implementation.
- Always keep usability in mind. What kind of training exists for administering a given solution, and how easily can employees be trained? “The human is an important part of the system,” Modi reminds.