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FDA GxP Compliance

The medical device industry is driven by innovation. At the same time, the industry is consistently being challenged to meet the rising standards of quality and achieve compliance with rigorous regulatory requirements. Among a litany of mandates and regulations these organizations have to monitor and manage, many are greatly impacted by FDA GxP compliance.

Traditionally, homegrown systems, stand-alone applications, or spreadsheet-based systems have been used to manage quality and compliance at the departmental level. Such point solutions lack a broad enterprise reach. That approach is losing relevancy, and even creating many problems for organizations trying to maintain the speed needed to compete.

To effectively overcome the burdens of FDA GxP compliance, organizations need to take an integrated approach with next-generation technology. The benefits go well beyond compliance. The right solution can lay the foundation for a competitive advantage that separates you from the crowded medical device market of manufacturers and suppliers.

Managing FDA GxP Compliance with IQS

IQS enables companies to take an integrated, risk-based approach to quality management and compliance. IQS enterprise quality and compliance management software creates a hub designed to simplify and streamline the way companies manage FDA GxP compliance.

With modules for risk management, document control, compliance training, and ongoing auditing, as well as recording and reporting on exception events and the resulting corrective actions, IQS is built to provide you with everything needed to manage and get ahead of FDA GxP compliance. Electronic records deliver the visibility needed to control the wide variety of impacts to compliance.

The IQS EQMS solution provides a comprehensive suite of FDA regulatory compliance software for automating GxP compliance processes. It offers embedded best practices that ensure ongoing compliance with FDA regulations. The solution significantly lowers the cost of regulatory compliance and creates an environment that proactively identifies, tracks, and resolves quality issues.

The IQS FDA GxP compliance solution is widely used in the life science industry for supporting key processes and requirements for 21 CFR Part 11, Part 210-211, and Part 820 compliance.

The ability to close the loop on quality management and compliance is key for medical device manufacturers. With IQS, organizations can use the integrated system to enable the levels of cross-functional communication and collaboration needed to manage FDA GxP compliance from end to end. Compliance no longer has to obstruct your pathway to innovation and growth.

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