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The Complete Solution for Veterinary Facility and Subject Management
Pristima Web Core Reproduction and Teratology module is an end-to-end enterprise solution designed for managing preclinical research data. The system supports phase-based study protocols and data management, addressing the needs of toxicology and reproduction/teratology studies. It enables the collection and management of data for dams, fetuses, and pups, including estrus cycle evaluation, mating data, c-section data, and developmental milestones. The module ensures compliance with 21 CFR Part 11 regulations, featuring electronic signatures and audit trails. Xybion offers flexible deployment options and comprehensive validation services to support global pharma companies and CROs in achieving quality and efficiency in their research processes.
Pristima Web Core Reproduction and Teratology is a robust data management and reporting tool tailored for preclinical research. This comprehensive solution includes features such as estrus cycle evaluation, mating and fertility data, interim and final c-section data, fetal pathology, and user-defined template formulation instructions. It supports a wide range of formulation types and manages litter data, including signs, weights, and mortality. Additionally, the tool facilitates culling and weaning activities, developmental milestones, and behavioral evaluations.
Fully integrated with Pristima Web Core, it ensures seamless workflow and complies with 21 CFR Part 11 for electronic signatures and audit trails. To meet GLP guidelines, the software undergoes a thorough validation process, covering project management, requirements documentation, and IQ/OQ/PQ test protocols. This ensures that the system operates effectively, efficiently, and in compliance with regulatory standards.
