Rosetta Biosoftware and Agilent announce first gene expression data analysis system to support compliance with 21 CFR/11
Rosetta Biosoftware and Agilent Technologies Inc announced the introduction of Rosetta Resolver(r) system, version 4.0. This new gene expression data analysis system, used to analyze genes for disease research and drug discovery, is the industry's first to support compliance with the U.S. food and Drug Administration's (FDA) 21 Code of Federal Regulations (CFR), Part 11.
The FDA regulation requires companies using computerized 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, Ph.D., 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 analyze 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
* 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 customize the Rosetta Resolver system to meet customers' specific electronic signature requirements.
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