FDA selects ComplianceQuest and Zolon PCS for enterprise quality system upgrade

The U.S. Food and Drug Administration (FDA) is updating its quality management infrastructure through a new partnership with ComplianceQuest and Zolon PCS. The transition will occur under a five-year Blanket Purchase Agreement (BPA) awarded to Zolon PCS, which will leverage ComplianceQuest’s cloud-based platform to manage quality, risk, and compliance operations.

The project aims to replace disparate processes with a unified system built on the Salesforce FedRAMP Government Cloud. The initiative focuses on four key areas: connected quality operations, centralized data visibility, the application of AI for investigation automation, and the implementation of scalable, secure infrastructure to meet federal standards.

ComplianceQuest CEO Prashanth Rajendran noted that the move reflects a broader shift in regulated industries toward integrated platforms. Zolon PCS President Goutham Amarneni highlighted the necessity of combining a robust platform with specialized federal delivery expertise to address the complexity of agency-wide operations.

This modernization effort is designed to improve consistency across FDA offices and centers by consolidating functions such as document control, auditing, and corrective actions into a single digital environment.