We are proud to announce that we have been ISO 9001:2008 Certified. This achievement confirms our adherence to rigorous quality management principles during the design, development, implementation, and servicing of SmartSolve, our Enterprise Quality Management Solution. We invite you to learn more about our achievement.
Are you prepared for the 8/14/15 eMDR compliance deadline? Learn how to plan for mandatory FDA electronic regulatory reporting requirements in this on-demand educational webinar.
SmartStart gets you live in just 30 days by leveraging pre-packaged configuration options derived from hundreds of successful implementations.
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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