Software used by pharmaceutical and biotechnology companies to detect and quantitate contaminants in biopharmaceutical products for 21 CFR 11 compliance
Molecular Devices Corporation has announced the introduction of Threshold Enterprise 1.0 software.
Used with Molecular Devices's Threshold immunoassay detection system, Enterprise 1.0 software provides the tools necessary for compliance with the US Food and Drug Administration (FDA) 21 CFR Part 11 Final Rule. Threshold is used by pharmaceutical and biotechnology companies worldwide to detect and quantitate contaminants in biopharmaceutical products.
These contaminants include host cell DNA, host cell proteins, bovine contaminants, such as BSA, IgG, insulin, and transferrin, proteins A and G, and any unique protein that can be bound by antibodies.
The Threshold system is applied to assay development, process development and quality control applications, often in highly regulated environments. "Threshold instruments and consumables are a mainstay of quality control in many of our customers' laboratories" stated Stephen Oldfield, vice president of marketing at Molecular Devices.
"By providing our customers with tools to meet their regulatory requirements, we are ensuring a continuing role for Threshold in quality and process control.
The security tools in the Threshold Enterprise software, the addition of a spike recovery report for analysis of the results within the software application, and a complete validation package allow current and future Threshold users to comply with the GLP/GMP/FDA 21 CFR Part 11." Specifically, Threshold Enterprise includes the following security tools: individual passwords and user IDs, permission-dependent access to major system features, audit trail of log-on and log-off activities and all user actions that modify the file, and signed electronic statements.
