As compliance standards become more stringent, FDA-regulated companies such as food, pharmaceutical and medical device manufacturers are implementing paperless quality systems for electronic records and traceability. By automating quality data collection, these companies can eliminate human error and comply with FDA regulations.

PAT
Simply stated, Process Analytical Technologies (PAT) are systems used for real-time quality assurance.

The FDA defines PAT as "systems for analysis and control of manufacturing processes based on timely measurements, during processing, of critical quality parameters and performance attributes of raw and in-process materials and processes to assure acceptable end product quality at the completion of the process.”

A key component of PAT is the use of real-time data, taken directly from the shop floor. This in-process data allows quality control professionals to take timely measures to prevent defects and ensure that the end product meets specifications.

The FDA has identified four PAT tools that help manufacturers better understand their processes:

• Multivariate tools for design, data acquisition and analysis
• Process analyzers
• Process control tools
• Continuous improvement and knowledge management tools

InfinityQS' real-time Statistical Process Control (SPC) software performs sophisticated statistical analysis on real-time data that helps quality professionals understand how their processes are performing. With real-time alerts, based on statistical control limits, operators are able to address quality issues at the source and prevent defective products at the end of the line.

Case Study
The Alcon Manufacturing Ltd. plant in Sinking Spring, Pa., process improvement is led by the quality assurance division. About three years ago, the quality assurance department began deploying statistical process control software from InfinityQS to automate data collection and analysis. The software uses statistical analysis to generate data via control charts and alerts. At the same time it improves processes for the purpose of compliance, it also helps improve operational efficiencies. Because many of the tiny medical components made at the plant must be crafted by hand, the company faces considerable challenges generating process improvement through automation.

The InfinityQS software allowed Alcon to improve speed by incorporating quality control into its manufacturing. The product is inspected at each step of production, rather than at the end only. Production workers have more control over the process, and the potential for errors is reduced. The first implementation reduced inspection time by about 50 minutes per lot, saving the company the equivalent of one full-time employee.

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