InfinityQS takes a proactive approach to help medical device and pharmaceutical manufacturers build quality into their products by giving them real-time visibility into production shop floor processes.
InfinityQS solutions dramatically reduce quality issues that lead to scrap, rework, warranties and recalls while providing an electronic framework that keeps companies in compliance with government regulations.
FDA 21 CFR Part 11 Compliance
InfinityQS supports the technical requirements of a 21 CFR Part 11 compliant Statistical Process Control system. Our CFR Part 11 features help protect companies governed by the FDA, but they also empower those who want to ensure the integrity of their data through good security practices.
Title 21 of the Code of Federal Regulations, Part 11; Electronic Records; Electronic Signatures (21 CFR Part 11) allows FDA regulated companies to take full advantage of electronic technology while ensuring their implemented systems are aligned with the FDA's responsibility to protect public health. More >>
Process Control, Lot Genealogy, Tracking and Reporting
By tracking and controlling products as they move throughout the supply chain and into your own facility, ProFicient provides confidence that supplier-manufactured products meet your most stringent quality standards.
Whether you’re looking to improve quality at a single plant or across the globe, InfinityQS’ hybrid quality system provides the tools needed to comply with regulations while dramatically reducing quality costs. More >>