Ensure Consistent Out of Specification (OOS) Lab Result Investigations

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 tools to:

  • Investigate consistently, every time.
    Our software mirrors the two-phase approach from the FDA’s guidance on OOS investigations to keep you compliant. Analyst and supervisor checklists ensure consistent investigations. Plus, you can easily show which test was followed by cross-referencing a standard operating procedure (SOP) or specification document. All investigation results are stored within one record for easy retrieval during an FDA inspection.
  • Resolve problems quickly through email alerts and personalized dashboards to help team members quickly weigh in with root cause analysis and investigation results.
  • 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.
  • Tailor, extend, and integrate your quality processes as the demands on your quality management system grow.

Let us operationalize your Out of Specification (OOS) Lab result investigations.