New Software for Agilent Bioanalyzer Features Unique RNA Quality Control, FDA Compliance Tools
Agilent Technologies Inc. (NYSE:A) today introduced new software for the Agilent 2100 bioanalyzer that includes a unique RNA Integrity Number algorithm for RNA quality control and tools for compliance with FDA rule 21 CFR Part 11, which governs data security, access and electronic signatures. The Agilent 2100 bioanalyzer is a groundbreaking lab-on-chip electrophoresis and flow cytometry analysis tool used for DNA, RNA, proteins and cells.
“More than 800 customers have downloaded the RIN beta release, and a recent survey indicates that most of them found it very valuable in their work,” said Tony Owen, marketing manager for Agilent’s Life Science and Chemical Analysis. “This is the first time that RIN is available in a commercial package, and we anticipate strong demand.”
The assessment of RNA integrity is a critical first step in obtaining gene expression data. Agilent 2100 bioanalyzer expert software B.02.01 extracts information about RNA sample integrity from a bioanalyzer electrophoretic trace and generates an easy-to-interpret RIN. To facilitate use of RIN and the overall data analysis, a second-generation Result Flagging tool has been incorporated, letting users define rules to automatically color flag samples based on diverse criteria at the sample or even the individual sample peak level.
The new 2100 bioanalyzer Security Pack provides productivity and compliance support features to address the data security, integrity and traceability requirements of FDA 21 CFR Part 11. The software offers result versioning and version management; user-independent, automatic audit trails; and electronic signing capabilities for electronic records. Access to the application is protected by mandatory logon with a user identification code and password.
Electronic records generated by the application are always stored with all related raw, meta and result data. The software seamlessly integrates with the 2100 bioanalyzer expert software, which supports key Good Laboratory Practice requirements such as installation qualification and operational qualification. With the completion of the compliance suite the bioanalyzer is now the preferred alternative for pharmaceutical QC, replacing gel electrophoresis, which is labor intensive and relatively inaccurate and unreliable.
About Agilent Technologies
Agilent Technologies Inc. (NYSE:A) is the world’s premier measurement company and a technology leader in communications, electronics, life sciences and chemical analysis. The company’s 28,000 employees serve customers in more than 110 countries. Agilent had net revenue of $7.2 billion in fiscal year 2004. Information about Agilent is available on the Web at www.agilent.com .
