SmartSolve OOS Management

Ensure Consistent Out of Specification (OOS) Lab Result Investigations

OOS Management Software System

Investigating Out of Specification (OOS) lab results is a necessity for every pharmaceutical and combination product manufacturer. Both cGMP and 21 CFR part 210 and 211 requirements guide the process for investigating OOS lab results for drug components, APIs, and finished drugs.

SmartSolve® Out Of Specification Management software keeps you in control of OOS lab result investigations, ensuring consistent intake, root cause identification, conclusions, and follow-up.

Our OOS software provides user-friendly OOS investigation tools to:

  • Investigate consistently, every time.
    Our Out of Specification software mirrors the two-phase approach from the FDA’s guidance on OOS investigations to keep you compliant. Analyst and supervisor checklists ensure consistent out of specification investigations, Plus, you can easily show which test was followed by cross referencing a standard operating procedure (SOP) or specification document. All out of specification investigation results are stored within one record for easy retrieval during an FDA inspection.
  • Resolve problems quickly.
    Keep everyone in the loop. Email alerts and personalized dashboards help team members quickly weigh in with root cause analysis and investigation results. Our milestone dates and escalation strengthen accountability by involving subject matter experts when they’re needed.
  • Integrate and escalate at exactly the right time.
    Not every OOS lab result will require a CAPA, SmartSolve’s integrated risk priority number (RPN) automatically creates the right CAPA at the right time by generating a new CAPA or attaching an OOS investigation to an existing CAPA record.
  • Identify out-of-trend (OOT) results to boost management oversight.
    Over time your data may show an underlying issue with a particular piece of equipment, test, or even lab analyst. OOT data and OOS investigation results tracked in our Out of Specification software can help you develop insight into systemic issues and improve your quality. Do you need to update the procedure for a test? Or require a lab analyst to recertify to his training requirements? SmartSolve’s intelligent reporting tools can help you reach the right conclusions.
  • Tailor, extend, and integrate your quality processes.
    Out of Specification Management system 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, Pilgrim's secure, cloud-based deployment options and automated validation tools help your team get up and running on new processes quickly.


Out Of Specification Management is an integrated part of our SmartSolve quality management software.


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