Resolver System and 21 CFR Part 11

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. As a result of the application of the technology in these areas to support regulatory filings, it is becoming critical that these 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^® Gene Expression Data Analysis 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.

Rosetta Biosoftware Professional Services also offers compliance assistance and customization to meet your specific electronic signature requirements.

Go to the Resolver System product page.