Technology
REGISTRAT-MAPI technologies are seamlessly integrated, as project requirements dictate, to provide optimal project-specific solutions. REGISTRAT-MAPI professionals research new technology and evaluate ways to enhance current technology for ease of use in clinical studies. Developers and support staff have the requisite experience to guide requirements and implement technologies for large clinical and observational studies.
REGISTRAT-MAPI validates all technologies to maintain compliance with appropriate regulatory guidelines. SOPs guide Validation Specialists working in cooperation with the Quality Assurance 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.
All 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.