Quality of Service
Data Protection and Disaster Recovery
All REGISTRAT-MAPI Technology systems are backed up as outlined by SOPs that govern electronic data back-up and recovery procedures. Multiple robotic libraries handle tape backups which are rotated to secure off-site locations as required. For business critical and clinical systems individual Disaster Recovery Plans (DRP) are created to address potential disasters.
Hosting
REGISTRAT-MAPI's secure server room is a raised floor, 1100 square foot, climate controlled facility which boasts multiple UPS redundancies as well as a full 480 KVA generator in case of power emergencies. Multiple internal and external monitoring systems proactively alert REGISTRAT-MAPI system administrators of potential issues, thus assuring a high percentage of uptime. Applications in the hosting center can be deployed in a secure DMZ, a segregated sub-network, or in any other manner necessary to facilitate maximum security and uptime on dedicated or shared hardware.
Virtual Private Networks
To facilitate consistent secure communication between a sponsor and REGISTRAT-MAPI, a VPN tunnel can be established. This tunnel can use low to high encryption and allows for secure transmission of study files, images, study information, data reports, and email. In setting up VPN connections with sponsors, REGISTRAT-MAPI segregates necessary servers using routing tables and appliances as necessary. Tunnels are monitored constantly to ensure uptime and allow companies to function as a seamless unit. REGISTRAT-MAPI Information Technology will work with a Sponsor or partner to establish guidelines, set requirements, set contingencies and create the monitoring points to achieve success. Once the VPN is implemented it is transparent to all end users and allows normal use of all Internet applications while securing data transmissions between the companies.
Validation and Testing
REGISTRAT-MAPI validates technologies to maintain compliance with appropriate regulatory guidelines. SOPs guide Validation Specialists working in cooperation with REGISTRAT-MAPI's QA Department to ensure proper standards are met or exceeded. The REGISTRAT-MAPI Software Development Lifecycle allows for flexibility in the creation of new systems while maintaining a high level of quality.
FDA (21 CFR Part 11), Electronic Signature Compliance
Required systems are developed, validated and maintained in compliance with the FDA's Proposed Rule on Electronic Signatures (21 CFR Part 11), Electronic Records. REGISTRAT-MAPI also validates in accordance with regulatory guidelines.