SmartSolve Deviation Management

Streamlined Deviation Management Software – Capture, Verify, and Investigate Product and Process Deviations

Deviation Management Software System

As a Pharmaceutical manufacturer, you are perpetually vigilant about conformance to industry requirements and product standards. Unexpected issues that impact products, processes, or materials can have huge financial impacts. So, when a deviation occurs, it is important to resolve it in a timely and compliant manner. SmartSolve® Deviation Management system is equipped with best practice workflows to identify, mitigate, and reduce the risks associated with unexpected events in your manufacturing process. Our Deviation Management system helps you:

  • Capture defects and assess their risk.
    Why take chances? Stay on top of risk. Our deviation handling and quality risk management software’s simple initiation form lets you quickly capture details like classification, type, source, category, incident date, any initial actions or containment, description of the event, and notation of impacted products and batches. This lets Deviation Management automatically adjust workflows or trigger alerts for critical products or high-risk deviations. Deviation Management provides trend analysis to help you monitor low-risk deviations and take action before they become critical issues.
  • Guide your team through the resolution process.
    Keep everyone in the loop. Email alerts and personalized dashboards help team members quickly weigh in with dispositions and investigation results. Our milestone dates and escalation triggers help you reduce deviation cycle time. These capabilities extend throughout your value chain — you can communicate quickly and clearly with suppliers when deviations affect them.
  • Create the right CAPAs at the right time.
    Not every deviation requires a CAPA. SmartSolve's risk calculations incorporate severity, occurrence, and detection ratings to ensure that CAPAs for high-risk deviations are created in a structured, consistent manner. Then, seamless integration with our CAPA Management solution automatically escalates risky deviations at exactly the right time. You can create a new CAPA or work with an existing record to streamline your process for related deviations.
  • Drive continuous improvement.
    Create an aging report or perform trend analysis within interactive quality intelligence dashboards. You can easily distribute reports to share deviation trends throughout your organization. These can be used to drive improvements in new product and process design, while aging reports can help you reduce deviation and overall cycle time.
  • Tailor, extend, and integrate your quality processes.
    Deviation Management is developed on SmartSolve's Platform for Compliance. SmartSolve's Configuration Tools, Platform Services, and Enterprise Integration capabilities make it easy to tailor, extend, and integrate processes as the demands on your quality management system grow. Plus, SmartSolve's secure, cloud-based deployment options and automated validation tools help your team get up and running on new processes quickly.


Deviation Management is an integrated part of our SmartSolve quality management software.


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