SPR Regulatory Tools for Drug Development
2 May 2008
Bio-Rad Laboratories has announced the pending launch later this year of two regulatory tools for the ProteOn XPR36 Protein Interaction Array System: the ProteOn Manager 2.1 Security Edition Software and the ProteOn XPR36 Installation Qualification and Operation Qualification Kit. These regulatory tools will be key to pre-clinical and clinical development of therapeutics as well as manufacturing and quality control.
The ProteOn Manager 2.1 Security Edition Software is designed to assist customers in pharmaceutical drug development meet the requirements for 21 CFR part 11 by providing functionality for maintaining data security, data integrity, auditing, and the traceability of electronic records.
The ProteOn XPR36 Installation Qualification and Operation Qualification (IQ/OQ) Kit will enable drug discovery and development researchers to validate and record instrument performance. The IQ/OQ kit has been designed to test critical system functions to ensure reliability and consistency of system performance. The kit will include control reagents, fully automated software, and reporting functions. Key benefits include wizard-driven software, printable electronic reports for document control, electronic log of IQ/OQ and test results, ready-to-use reagents and sensor chip for testing system performance, and unattended operation.