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Section One

How Far Does Annex 11 Go Beyond Part 11?

Mon, 09/19/2011 – 4:19am
Ken Appel, Manager of Regulated Markets, Vaisala

The Food and Drug Administration’s (FDA) Part 11 (21 CFR Part 11) and the European Union’s (EU) Annex 11 (EUDRALEX) Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice (GMP), Medicinal Products for Human and Veterinary Use) share the same intent. Namely, all computerized systems used in GxP-regulated environments require compliance for ensuring integrity of records and data. Annex 11 moves beyond Part 11 for some obvious reasons – time and approach.

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More Advanced Biometrics Tech Coming With iPhone 6S

Posted on May 15, 2015

The KGI Securities report expressed the most enthusiasm over its “Force Touch” input, which will apparently allow readings of finger movements on the screen so refined that it can be used for handwritten notes and the like. And the Touch ID fingerprint sensor will apparently be more advanced both in its speed and security, which could prove important as Apple Pay competes against other mPayment platforms.

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Section Two

European Commission Annex 11

EudraLex
The Rules Governing Medicinal Products in the European Union

Volume 4
Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use

Annex 11: Computerised Systems

This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.

The application should be validated; IT infrastructure should be qualified.

Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.

Commission Européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel – Belgium
Telephone: (32-2) 299 11 11

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EyeLock Introduces Enterprise myris™ – The First Iris Authentication Solution Engineered Specifically for the Enterprise Market

EyeLock, Inc., a market leader of iris-based identity authentication solutions, introduces enterprise myris, a USB-enabled iris identity authenticator providing the most convenient and secure way for companies large and small to authenticate and manage  employees’ digital identities.

As the first USB-powered accessible iris authentication product specifically engineered for enterprise use, enterprise myris enables the use of best practices for password protocols and mitigates vulnerabilities associated with the password breaches and security issues facing companies.

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Section Three

IT Adoption of Biometrics Accelerates

by    BOB VIOLINO
SEP 10, 2015 9:35am ET
Biometrics IT Security Adoption Accelerates

Biometrics technology continues to have an increasing impact on the security market, particularly in government. The global biometrics spending market in the government sector will grow at a compound annual growth rate (CAGR) of more than 14% between 2015 and 2019, according to new research from Technavio.

North America accounts for the largest market share, with about 33%, thanks to the U.S. and Canadian governments investing in a number of biometric solutions, the report says.

Advantages, such as high-security and continuous monitoring and reliability, are driving demand for cloud-based biometrics in the government sector. E-voting is a new government initiative in many countries, made possible by the use of cloud-based biometrics.

Governments of many countries are also adopting biometrics to monitor employee attendance, rationing, and border control. For instance, Unique Identification Authority of India (UIDAI) has been issuing a biometric scanning card for attendance systems in government organizations.

“Governments are adopting multi-modal [biometrics], which is a combination of biometric technologies such as fingerprint, face, palm, vein and iris recognition,” Navin Rajendra, lead analyst, IT hardware, software and services at Technavio, said in a statement.

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Bill Burr’s 2003 NIST report recommended using numbers, obscure characters and capital letters and updating regularly—he regrets the error...

The Man Who Wrote Those Password Rules Has a New Tip: N3v$r M1^d!

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Section Four

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