Regulatory tools, includes 1–user license for ProteOn Manager™ software, Security Edition (#176–0210), ProteOn XPR36 IQ/OQ kit (#176–4200).
Tools are available with the ProteOn XPR36 protein interaction array system to facilitate regulatory compliance in the drug discovery and development workflows. ProteOn Manager software, Security Edition, and the ProteOn XPR36 installation qualification/operation qualification (IQ/OQ) kit assist the user in adhering to the good practices rulings observed by the pharmaceutical industry. These rulings require procedural (notification, training, and operational), administrative, and technical (software-related) control changes.
ProteOn Manager Software, Security Edition
New compliance features enable users to turn on security features that comply with U.S. FDA21 CFR Part 11 regulations. Features of the Security Edition software include audit trails, electronic signatures, data validation, user logins and permissions, and closed-system security. Signatures can be verified, ensuring data consistency within the instrument.
The ProteOn XPR IQ/OQ kit is designed to test critical system functions and to ensure the reliability and consistency of system performance. Key features include:
- Intuitive wizard-driven software
- Printable electronic reports for document control
- Electronic log of IQ/OQ and test results
- Ready-to-use reagents
- Sensor chip for testing system performance with walk-away unattended operation