Complex Deviation Investigation
Solve Complex Investigations and Identify Systemic Root Causes
When your team is stuck on a complex deviation or OOS investigation, GMPKit deploys our proven approach, investigation specialists, and analytical experts to identify root causes and design effective CAPAs.
The Complex Investigation Problem
Complex deviations and OOS investigations require specialized expertise, structured methods, and the ability to identify systemic root causes—not just document what happened.
Investigation is Stalled
Your team has been investigating a complex deviation or OOS for weeks or months—unable to identify root cause or design effective CAPAs.
Recurring Problems
The same deviations keep happening across products or sites—indicating your investigations aren't identifying systemic root causes.
Specialized Expertise Needed
The investigation requires analytical, process, or technical expertise your team doesn't have—creating delays and compromising investigation quality.
How GMPKit Solves This
We solve complex investigation problems by applying our proven approach and GMPKit toolset to your specific situation—combining investigation expertise, structured methods, and capability building.
Deploy Investigation Specialists
We deploy experienced investigation specialists to lead complex deviation and OOS investigations—bringing structured investigation methods and root cause analysis expertise.
Learn About Our SME NetworkDiagnose Investigation Constraints
We use our diagnostic frameworks to identify why investigations are stalling—whether it's investigation methodology, analytical capability, or cross-functional collaboration gaps.
Explore Diagnostic FrameworksApply Structured Investigation Methods
We deploy proven investigation frameworks—from initial assessment through root cause identification to CAPA design—ensuring investigations are thorough and defensible.
Learn About Our Diagnostic ApproachBuild Internal Investigation Capability
We train your team on structured investigation methods while solving the immediate problem—building capability so future investigations don't stall.
Explore Leadership DevelopmentExpert Intervention When Needed
Our experience, tools, and SME network help us solve complex investigation problems quickly—deploying the specialized expertise needed to identify root causes and design effective CAPAs.
Quality System Architects
We deploy QA experts who've solved complex investigations across pharmaceutical manufacturing—bringing proven methods and structured investigation frameworks.
Manufacturing Experts
When deviations stem from operational execution issues, we bring in manufacturing specialists to identify systemic root causes and design preventive actions.
AI Workflow Experts
We deploy AI specialists to analyze patterns across deviations, identify hidden correlations, and accelerate root cause identification.
Results You Can Expect
Within weeks, you'll have identified root cause, designed effective CAPAs, and built your team's capability to handle future complex investigations independently.
- Root cause identified in weeks, not months
- Effective CAPAs that prevent recurrence
- Regulatory-defensible investigation reports
- Improved investigation capability for your team
- Reduced investigation cycle times going forward
Getting Your Strategy Back on Track:
Our experience, tools, and SME network help us solve complex investigation problems quickly—getting your quality strategy back on track and preventing recurring deviations that drive up COPQ and threaten regulatory compliance.
Ready to Solve Your Complex Investigation?
When your team is stuck on a complex deviation or OOS investigation and needs specialized expertise, let's discuss how GMPKit can deploy our proven approach to identify root causes and design effective CAPAs.