Bio-Rad Enhances Imaging and Gel Analysis Software With First Ever 21 CFR Part 11 Compliance Features

Friday December 05 2008 | Biotechnology feed | All feeds

Bio-Rad Enhances Imaging and Gel Analysis Software With First Ever 21 CFR Part 11 Compliance Features
HERCULES, CA September 15, 2003 Bio-Rad Laboratories, Inc. (AMEX: BIO and BIO.B) announced today that it has added regulatory functionality to The Discovery SeriesTM software used for imaging and analyzing gels and blots. This software is the first gel and blot imaging software to be compatible with FDA 21 CFR Part 11 regulations (Electronic Records; Electronic Signatures).

Bio-Rad¹s Quantity One® 1-D analysis software and PDQuest 2-D analysis software programs are used in thousands of laboratories worldwide for basic research, drug discovery and quality control of DNA and protein samples. Now, with the new Quantity One 4.5 and PDQuest 7.2 software, users can satisfy Federal Food and Drug Administration control requirements for electronics record systems and electronic signatures under FDA 21 CFR Part 11 regulations relating to gel electrophoresis imaging and analysis. Companies developing and manufacturing drugs and cosmetics are required to meet these regulations.

Easy-to-use Quantity One software provides image analysis tools, enabling researchers to clearly visualize their first dimension electrophoresis data. PDQuest is designed for laboratories running large numbers of 2-D gels simultaneously, offering the most powerful 2-D analysis tools on the market.

"Researchers' needs are constantly changing, and we are committed to delivering innovative solutions to meet those needs," said Martina Palm, Bio-Rad Software and Bioinformatics Business Unit Product Manager. "Since our software is used by both academic and commercial researchers who require differing 21 CFR Part 11 compliance functionality, we offer this as an optional module."

System access and data security

The Discovery Series' new security model operates in tandem with Microsoft Windows operating system¹s security functions. The CFR modules require Windows 2000 or Windows XP Professional to comply with the FDA regulation (imaging analysis applications also run on Mac OS 9 and Mac OS X operating systems). This security function provides access controls and authority checks via user identification codes and passwords, enabling varying levels of authority to be assigned to system administrators, users, technicians and guests.

Original raw data is saved in a backup file that cannot be modified or accessed by unauthorized users. Additionally, records created on 21 CFR Part 11 systems cannot be opened on non-compliant systems. Conversely, records created on non-compliant systems cannot be opened on 21 CFR Part 11 systems.

Audit trails
Secure, time-stamped audit trails are implemented within Quantity One and PDQuest to independently record date and time of operator entries and actions that create, modify, or delete electronic records.

Electronic signatures

The name, date, time, and reason for each signature is stored as part of each electronic record. When a signature is performed, the associated data is automatically saved and locked.

Powerful, flexible applications

Bio-Rad's Quantity One is a powerful, flexible package for imaging and analyzing 1-D electrophoretic gels, blots, and colonies. The software can quantitate and analyze a variety of data, including radioactive, chemiluminescent, fluorescent, and color-stained samples acquired from densitometers, storage phosphor imagers, fluorescent imagers, and gel documentation systems.

PDQuest , with over 100 published references to its credit, offers "Best in Class" performance for the analysis and databasing of 2-D gels. Designed for laboratories that simultaneously analyze multiple gels, this software eliminates major bottlenecks in 2-D gel analysis by automating the processing of gel images and seamlessly integrating that data with instruments and software used in the proteomic discovery process. With powerful comparative analysis tools as well as extensive data linking and annotation capabilities, PDQuest provides an ideal window through which users can conveniently view all their protein regulation and characterization data.

Bio-Rad Laboratories, Inc. (www.bio-rad.com) is a multinational manufacturer and distributor of life science research products and clinical diagnostics. It is based in Hercules, California, and serves more than 70,000 research and industry customers worldwide through a network of more than 30 wholly owned subsidiary offices.

Various statements made within this press release may constitute "forward-looking statements" for purposes of the Securities and Exchange Commission¹s "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995 and Rule 3b-6 under the Securities Exchange Act of 1934. The forward-looking statements contained herein involve risks and uncertainties that could cause results to differ materially from the Company¹s expectations.

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For more information call 800-424-6723 (800-4BIO-RAD), visit discover.bio-rad.com , or contact:
Product information:    Reader inquiries:
Martina Palm, Product Manager, Imaging Products    Debbie Schantz
Phone: (510) 741-5394    2000 Alfred Nobel Drive
E-mail: martina_palm@bio-rad.com    Hercules, CA USA 94547
   e-mail: debbie_schantz@bio-rad.com # # #

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