21 CFR Part 11 Quality System Implementation

The University at Buffalo is seeking a qualified consultant to develop and implement a comprehensive Quality System that ensures compliance with 21 CFR Part 11 regulations, which establish criteria for electronic records and signatures to be considered trustworthy and equivalent to paper documentation. This initiative is driven by the University's expanding clinical research activities involving electronic systems that fall under Part 11 scope. The goal is to create a program that demonstrates to the FDA the integrity and reliability of electronic signatures and records maintained by the University. The contract, valued between $500,000 and $2,000,000, is set for a one-year period with a due date for proposals of December 13, 2024, and is located within Erie County, New York. The procurement emphasizes diversity and inclusion, with specific subcontracting goals: 16% for minority-owned businesses, 14% for women-owned businesses, and 6% for service-disabled veteran-owned businesses, although it is not set aside specifically for service-disabled veteran-owned entities. The contract is managed by the State University of New York (SUNY) and is open to organizations with relevant experience, including those that have previously secured similar contracts, such as PQE Group. The primary contact for this solicitation is Bethany Scibetta, Senior Buyer, accessible via email and phone. The project aims to ensure regulatory compliance and strengthen the University’s capacity to uphold the integrity of electronic records in accordance with federal standards.