The document discusses how biometric systems can provide strategic advantages for pharmaceutical manufacturers. It notes that the pharmaceutical industry faces increasing regulatory requirements for workflow enforcement and event traceability. Biometric technologies for access control, authentication, electronic signatures, and event traceability can help companies reduce costs and time needed to comply with regulations while also protecting intellectual property and improving productivity. The document outlines some obstacles to adoption of biometric technologies in pharmaceutical manufacturing but argues these obstacles are minimal as the technologies have matured and cultural resistance is diminishing. It recommends that suppliers continue enhancing functionality to reduce validation costs and that users thoroughly evaluate biometric solutions.

1. THOUGHT LEADERS FOR MANUFACTURING & SUPPLY CHAIN
ARC INSIGHTS
By John Blanchard
Biometric systems help reduce the cost
and time to achieve and maintain
compliance, protect intellectual
property, improve manufacturing
productivity and safety, and reduce
system administration costs.
INSIGHT# 2003-22MH
JUNE 11, 2003
Biometrics Provide Strategic Business
Advantage in Pharmaceutical Manufacturing
Keywords
Biometrics, Pharmaceutical, Security
Summary
The pharmaceutical industry is faced with increasing regulatory require-
ments to provide work flow enforcement and event traceability as well as
to ensure the integrity, authenticity, and confiden-
tiality of electronic records. This requires physical
and logical security that includes policies, proce-
dures and technology. Consequently,
pharmaceutical manufacturers will be the first to
deploy biometric technology. Biometrics-based
access, authentication, electronic signature, and
event traceability systems also reduce the cost and time to achieve and
maintain compliance with current and future FDA regulations, protect in-
tellectual property, improve manufacturing productivity and safety, and
reduce system administration costs.
Analysis
Revenues in the biometric solutions market in 2002 were slightly over 500
million dollars and are projected to exceed 3.5 billion dollars by 2008. By
2005 it is estimated that private sector use will exceed public
sector use. Originally used primarily for physical site security,
biometrics are increasingly being used for logical security of
computer based systems. Biometric applications currently
used extensively in the service industries are beginning to be
applied to plant automation systems within manufacturing.
This includes both office and plant floor applications. The
primary applications are access control, authentication of per-
sonnel, electronic signatures, and event traceability. Their use
in manufacturing is being driven by business and regulatory
requirements to protect electronic records from unauthorized use and to
ensure that work flow processes are followed. The highly regulated phar-
Biometrics Provide Fast
Access and Signature Non-
repudiation on the Plant Floor

2. ARC Insights, Page 2
©2003 • ARC • 3 Allied Drive • Dedham, MA 02026 USA • 781-471-1000 • ARCweb.com
maceutical industry will be one of the first to extensively deploy biometric
technologies in manufacturing as they move from inherently secure paper
records to electronic records systems and from manual operations to highly
automated operations. These highly automated operations will include ba-
sic research, clinical trials research, clinical trials manufacturing,
commercial manufacturing, post-manufacturing quality evaluation correc-
tive and preventative action programs (CAPA), and other highly regulated
aspects of the drug product life cycle. Today, the benefits of biometric
technology far exceed the limitations, particularly to ensure the integrity,
authenticity, and confidentiality of regulated records.
Business and Regulatory Drivers to Deployment
The pharmaceutical industry has become a global collaborative enterprise
with many alliances and outsourcing of basic research, clinical trials, and
even manufacturing. Electronic based record keeping is increasing rapidly.
Global consumer demand for available and
affordable drugs continues to grow, leading to
counterfeit and illegal drug manufacturing and
trafficking. In the pharmaceutical industry
there is also a need to protect intellectual prop-
erty because patented and non-patented
intellectual property is the primary source of
revenue.
E-records regulations and their interpretation
continue to evolve across the globe. In the US
this includes 21 CFR Part 11, as well as the
FDA’s GMP and Process Analytical Technol-
ogy (PAT) initiatives. In Europe, this includes Annex 11 of the EU GMPs,
electronic Signatures Directive 1999/93/EC, and Data Protection Directive
95/46/EC. The European Data Protection Directive requires more security
on more data than the current FDA regulations and extends this require-
ment to clinical trials patients regardless of country of residence. Although
anonymized data falls outside this European directive, some interpretations
question whether any clinical trails data associated with an individual di-
rectly or indirectly can be anonymized. All clinical trials data may require
maximum security to remain compliant with regulations.
Increased Security for Intellectual Property
Increased Security for Regulated E-Records
Ease of Compliance with Current and Future
Regulations
Improved Operational Efficiency and Safety
Improved Work Flow Enforcement
Reduced Administrative Costs
Understanding of Risk Based Approach and Gap
Analysis of Regulated Systems
Business and Regulatory Drivers in the
Pharmaceutical Industry

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©2003 • ARC • 3 Allied Drive • Dedham, MA 02026 USA • 781-471-1000 • ARCweb.com
Biometric technology is more than access and authentication. It enables the
identification and continuous tracking of an individual’s actions. This
traceability provides more visibility of events and more ability to enforce
workflows. It is estimated that a typical computer system user spends as
much as 1 to 2 percent of his or her time on logins and that password man-
agement costs more than 100 dollars per person per year. Biometric
technology provides faster access and reduces password management.
Deployment of a security system includes policies, procedures, and some
level of technology dependent upon the risk associated with a particular
system. The pharmaceutical industry is already familiar with this type of
risk assessment and gap analysis because they use the same risk-based ap-
proach for regulatory compliance. This will further speed deployment of
biometric technology applications.
Obstacles to Technology Deployment
The obstacles preventing rapid deployment of biometric technology in
pharmaceutical manufacturing have become minimal. The sensor technol-
ogy has matured. Most supporting software
has compliance-enabling functionality to en-
sure the authenticity, integrity, and
confidentiality of e-records. Suppliers continue
to develop additional functionality to further
reduce the cost and time of validation and meet
evolving requirements.
E-records regulations are still evolving and sub-
ject to interpretation. Interpretation of what
constitutes an environment for signature non-
repudiation is one example. Screen time outs and slow password access are
a safety concern on the plant floor, leading some to question the level of
security required. Biometric technology can provide an environment for
signature non-repudiation in a plant floor multi-user environment while
keeping critical operator screens active.
Over the past few years biometric technology has become a part of every-
day life. We have come to recognize its convenience and improved
security. Cultural resistance is diminishing rapidly. Biometric solutions
usually require newer computing technology, which some companies do
not have. A typical manufacturing site has multiple disparate systems with
Maturity of the Technology and Applications
Functionality
Understanding of Regulatory Requirements
Lack of Recognition of Security Requirements
Resistance to New Technology
Resistance to Cultural Change
Installed Technology Base
Obstacles to Biometrics Deployment in the
Pharmaceutical Industry

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©2003 • ARC • 3 Allied Drive • Dedham, MA 02026 USA • 781-471-1000 • ARCweb.com
inconsistent or non-existent access security. Biometrics can be deployed on
these systems eliminating the need for costly upgrades and provide a con-
sistent access methodology. Consistent access methodologies are just good
business practice and may one day become a regulatory requirement.
Recommendations
• Suppliers must continue to add functionality to reduce the cost and
time to achieve and maintain compliance. This requires a thorough un-
derstanding of regulated e-records requirements.
• Users should thoroughly evaluate biometric technologies to understand
the benefits this technology can provide in achieving and maintaining
regulatory compliance and protecting intellectual property.
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