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Rosetta Resolver System

Features | More Information | Support | qPCR Module | 21 CFR Part 11 

As gene expression analysis and the incorporation of these data have moved from basic research to translational research, biologists and bioinformatics researchers alike are challenged with using and exchanging data and analysis methods from many technologies, public data sources, internal data sources, and pathway content providers.

The Rosetta Resolver® system provides a central analysis center and repository for biologists, statisticians, and bioinformaticians for the evaluation of gene expression data from microarrays and qPCR studies.

Several types of researchers can benefit from the Resolver System:

  • Directors and Principal Investigators – Rely on compliance and reproducibility. Use comprehensive reporting tools that support efforts for 21 CFR Part 11 compliance. Learn how the Resolver system is in use at the FDA.
  • Core Lab Directors – Acquire results quickly. Automate analysis methods and easily manage large volumes of data from different array types.
  • Bioinformaticians/Statisticians – Deploy analysis methods throughout your organization. Create analysis methods in R, Java, and Matlab and make them available to all users through a central analysis center.
  • Biologists – Easily visualize and share your results. Take advantage of a comprehensive suite of visualization and collaboration tools.
  • IT Specialists – Ensure security. Manage multiple users and store large volumes of data.

Features

  • Scalable, secure data repository.
  • Standardized analysis methods, as well as the ability to create new methods or access public methods.
  • Data exchange between internal or external collaborators, as well as with the FDA.
  • Cross-species and/or cross-technology analyses:
    • e.g., comparisons of Affymetrix® versus Agilent arrays or optionally, qPCR versus microarrays.
  • Provides support for 21 CFR Part 11 compliance, as validated by industry audits.
  • Analysis environment which allows advanced users to create analysis workflows and templates for novice users.
  • Data analysis reports that contain information about how analyses were conducted and how visualizations were created.
  • Support for data standards:
    • CDISC/SEND format.
    • MIAME-compliant.
  • Technology-specific error models in the system.
  • Automated data import tools.
  • Support for gene expression data from multiple technologies:
    • Affymetrix
    • Agilent
    • Illumina®
    • GE Healthcare
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More Information

For information about purchasing the Resolver system, please contact our Sales Team.

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Support

Visit the Resolver Support Web site to access the following information (you must be a registered user to log in):

  • Documentation
  • Downloads
  • Software updates
  • Known issues
  • User forum
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qPCR Module

The qPCR analysis module is an optional component available with the Resolver system. The module allows you to leverage the data management and analysis capabilities of the Resolver system to import, store, and analyze quantitative real-time polymerase chain reaction qPCR data.

Specifically, the module includes:

  • Validation of microarray results with cross-qPCR and microarray analysis.
  • Ability to automate common qPCR analysis workflows.
  • Direct import of relative quantity (RQ) and absolute quantity data (AQ) generated by ABI instruments.
  • Specific quality control tools for qPCR analysis including visualizations of plate data.
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21 CFR Part 11

As gene expression data analysis is playing an increasing role in pharmaceutical and biotech drug development pipelines in areas such as toxicogenomics, clinical studies and molecular diagnostics to support regulatory filings, it is becoming critical that gene expression data analysis applications enable compliance with regulations such as 21 CFR Part 11.

The US Food and Drug Administration's (FDA) 21 CFR Part 11 requires companies using technologies and systems to manage data in the research, manufacture or management of any FDA-regulated product to provide documented evidence of electronic data compliance and verification that the system secures the regulated data. The Rosetta Resolver® system supports compliance with 21 CFR Part 11.

To meet the requirements set forth in this regulation, Rosetta Biosoftware has superior internal operations that enable pharmaceutical and biotech companies to comply with 21 CFR Part 11. Rosetta Biosoftware has engineered the Resolver system with the necessary technical controls to enable customer compliance with 21 CFR Part 11.

The Rosetta Resolver system provides:

  • Audit Trail - Enable time-stamped audit trails to record the date and time of operator entries and actions that create, modify, or delete electronic records.
  • Advanced Security - Configurable security protocols and authority checks allow regulation, management and audit of user access.
  • Accurate and Complete Records - Archives raw data and associated metadata for retrieval.
  • Electronic Signatures - With assistance from Rosetta Biosoftware's Professional Services group, enables user customization to adhere to electronic signature requirements.
  • Documentation to Support Compliance - Comprehensive technical documentation that enables system operation in a manner consistent with the requirements set forth in the 21 CFR Part 11 regulations.
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