Medical Device Directory

Efficiently Compliant: Using an SPC system to comply with the FDA’s CFR Part 11 requirements

A free white paper by InfinityQS

Explore the FDA’s CFR Part 11 requirements for electronic records and signatures. Discover how the right statistical process control (SPC) software program can help your organization become compliant with these rules in an efficient way. Companies that are regulated by the FDA must comply with a set of rules that can, at times, prove to be extremely onerous, even for the most organized firm. An SPC system is a software program that helps these over-burdened firms to meet the terms of FDA compliance. By utilizing statistical methods to observe and control various business processes, an SPC can effectively streamline a firm’s operations.

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