THOUGHT LEADERS FOR MANUFACTURING & SUPPLY CHAIN
ARC INSIGHTS
By John Blanchard
Biometric systems help reduce the cost
and...
ARC Insights, Page 2
©2003 • ARC • 3 Allied Drive • Dedham, MA 02026 USA • 781-471-1000 • ARCweb.com
maceutical industry w...
ARC Insights, Page 3
©2003 • ARC • 3 Allied Drive • Dedham, MA 02026 USA • 781-471-1000 • ARCweb.com
Biometric technology ...
ARC Insights, Page 4
©2003 • ARC • 3 Allied Drive • Dedham, MA 02026 USA • 781-471-1000 • ARCweb.com
inconsistent or non-e...
Upcoming SlideShare
Loading in …5
×

Biometrics Provide Strategic Business Advantage in Pharmaceutical Manufacturing

1,060 views

Published on

Biometrics Provide Strategic Business Advantage in Pharmaceutical Manufacturing
The pharmaceutical industry is faced with increasing regulatory requirements
to provide work flow enforcement and event traceability as well as
to ensure the integrity, authenticity, and confidentiality
of electronic records. This requires physical
and logical security that includes policies, procedures
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 intellectual
property, improve manufacturing productivity and safety, and
reduce system administration costs.

Published in: Technology, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
1,060
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
5
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Biometrics Provide Strategic Business Advantage in Pharmaceutical Manufacturing

  1. 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. 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
  3. 3. ARC Insights, Page 3 ©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
  4. 4. ARC Insights, Page 4 ©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. Please help us improve our deliverables to you – take our survey linked to this transmittal e-mail or at www.arcweb.com/myarc in the Client Area. For further information, contact your account manager or the author at jblanchard@arcweb.com. Recommended circulation: MAS-H clients. ARC In- sights are published and copyrighted by ARC Advisory Group. The information is proprietary to ARC and no part of it may be reproduced without prior permission from ARC.

×