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  • smartsolve

    SmartSolveEnterprise Quality Management

    The most complete EQMS and Compliance Suite.

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  • Frost & Sullivan Award 2016

    AWARD WINNING INDUSTRY LEADERSHIP

    2016 Frost & Sullivan Award Winner

    Customers and analysts agree!

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  • Better Together Webinar Image

    BETTER TOGETHER

    Avoid FDA 483s

    Integrated Nonconformance and CAPA Management working together.

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  • Out Of Specification Management Software

    SmartSolveOut Of Specification Management

    Conduct consistent laboratory investigations and reduce regulatory risk.

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  • automated validation

    SmartSolveAutomated Validation

    Eliminate the burden of validating your quality management software applications.

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    SmartSolveValidated & Certified

    Validated Platform, Solutions, and Cloud Offering. ISO 9001:2008 Certified.

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Your Partner in Enterprise
Quality Management
for Life Sciences

Why is Quality Management Important to you?

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.
Explore our Quality Management Software

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

Why is Compliance Management Important to you?

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. 
Explore our Compliance Solutions

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

Why is Risk Management Important to you?

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. 
Explore our Risk Solutions

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

Why Pilgrim?

Why Pilgrim?

Hundreds of Customers

Case Study

Learn how SmartSolve has helped a rapidly growing contract manufacturer comply with cGMP requirements and improve customer service. 

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From Our Blog

Evaluating the Cost of Quality: It’s Simple Math

The focus of any effective quality system is, and rightly so, all about ensuring Patient Safety.

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FREE E-book

Finding Your Path
to Quality Nirvana

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