InfinityQS supports the technical requirements of a 21 CFR Part 11 compliant Statistical Process Control system. Our 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.

Part 11 of Title 21 of the Code of Federal Regulations; 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.

InfinityQS is helping companies such as Abbott Labs, Novartis, Cordis, Alcon, Baxter decrease costs, increase efficiency and help meet regulation compliance. Click here for a longer list of our FDA regulated customers.

InfinityQS' SPC software is a Process Analytical Control Technology (PAT) that allows manufacturers to analyze in-process data so that the end product meets specifications. For more information about PAT, visit our pharmaceutical page.

Are you in compliance?

• Is your present SPC system robust and accurate enough to stand up to an FDA Audit and meet the requirements of 21 CFR Part 11?
• Can you quickly and easily generate reports to satisfy your most demanding internal and regulatory partners?
• Can you quickly create lot traceability and lot genealogy reports?

Download our White Paper to learn more about the FDA’s CFR Part 11 Requirements and how SPC software can help you meet them. View the InfinityQS overview of regulatory compliance and electronic traceability.