System used to analyse genes for disease research and drug discovery, is the industry's first to support compliance with US FDA's rule on electronic records and signatures
Rosetta Biosoftware, a provider of bioinformatics solutions, and Agilent Technologies have announced the introduction of Rosetta Resolver system, version 4.0.
This new gene expression data analysis system, used to analyse genes for disease research and drug discovery, is the industry's first to support compliance with the US Food and Drug Administration's (FDA) 21 Code of Federal Regulations (CFR), Part 11.
The FDA regulation requires companies using computerised technologies and systems to manage electronic data involved in the research, manufacture or management of any FDA-regulated product to provide documented evidence of data compliance and verification that the system secures the regulated data.
"This advancement leverages Agilent's expertise as a leader in delivering solutions for compliance with 21 CFR Part 11 to drug development labs," said Ludwig Huber, worldwide product marketing manager responsible for Agilent's compliance program.
"We understand the imperative for technologies used in drug development to meet regulatory requirements and are committed to expanding our compliance efforts in gene expression as its applications extend to toxicogenomics, clinical studies and molecular diagnostics.
We are excited about the introduction of version 4.0 of the Rosetta Resolver system as the first step in enabling FDA-compliant gene expression research." The Rosetta Resolver system, which is used to store, manage and analyse gene expression data, enables pharmaceutical and biotechnology companies to comply with 21 CFR Part 11 by providing key electronic data management capabilities, such as: Electronic audit trail - the Rosetta Resolver system version 4.0 has features that enable time-stamped audit trails to record the date and time of operator entries and actions that create, modify, or delete electronic records to support requirements detailed in Part 11; Advanced security - the Rosetta Resolver system's configurable security protocols and authority checks allow regulation, management and audit of user access; Accurate and complete copies - the system archives raw data together with meta-data for retrieval; and Documentation to support compliance - version 4.0 is delivered with technical documentation that enables customers to operate the system in a manner consistent with the requirements set forth in Part 11. Furthermore, Rosetta Biosoftware's Professional Services can customise the Rosetta Resolver system to meet customers' specific electronic signature requirements.
Rosetta Biosoftware has joined the PDA-licensed Audit Repository Center (ARC) as a participating supplier.
The ARC enables customers to acquire independent, third-party audit reports documenting Rosetta Biosoftware's development practices and quality standards in support of 21 CFR Part 11 compliance efforts.
"One of our goals at Rosetta Biosoftware is to empower our customers with solutions that meet the growing needs of today's drug discovery researcher," said Douglas E.
Bassett, vice president and general manager of Rosetta Biosoftware. "Version 4.0 of the Rosetta Resolver system, which is the first commercially available gene expression analysis product engineered to support compliance with 21 CFR Part 11, is a powerful step forward.
Along with a wealth of new analysis capabilities, the enhancements in version 4.0 allow our customers to focus on their research knowing that they are working on a top quality, robust technology platform that fosters regulatory compliance." In addition to support for compliance with 21 CFR Part 11, Rosetta Resolver system version 4.0 has been significantly enhanced with powerful new analysis algorithms and features such as Visual Scripting -- a powerful, easy-to-use scripting and automated analysis feature designed specifically for the research scientist.
Researchers can script and automate common analysis tasks to enhance productivity.
