Quality management processes enhance product quality, improve patient safety, and are required for regulatory compliance. When you automate with SmartSolve®, you will have more consistent processes, tighter controls and better visibility into what’s working and what’s not.
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A stringent quality compliance program supported by robust tools can prevent unsafe, dangerous or shoddy products from reaching the market."
Gartner, "Hype Cycle for Life Sciences," July 2013, S. Lefebure and S. Jacobson
Regulatory bodies set standards you must satisfy to sell medical products in their markets. We offer the tools you need to automate critical processes and comply with regulatory requirements.
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Companies that have implemented closed-loop quality management processes are better able to capture downstream quality data and deliver it upstream for continuous improvement. This results in more robust quality management systems and improved product compliance."
LNS Research, Matthew Littlefield, President and Principal Analyst, 2014
Product deviations and supplier disruptions can shut down operations. Armed with the risk calculations in SmartSolve, you will have the insights you need to reduce quality risks and improve operations.
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Effective quality risk management can facilitate better and more informed decisions, provide regulators with greater assurance of a company’s ability to deal with potential risks, and beneficially affect the extent and level of direct regulatory oversight."
ICH Q9 Guidelines
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