Investigations — Finding What Actually Went Wrong
Quality & Compliance
Investigations — Finding What Actually Went Wrong
Rigorous, defensible quality investigations that identify true root causes, support regulatory reporting obligations, and drive sustainable corrective action.
Quality investigations are among the most consequential activities in a regulated operation. A well-conducted investigation protects product quality, supports regulatory reporting, and drives genuine improvement. A poorly conducted investigation — one that reaches a convenient conclusion without identifying the true root cause — creates regulatory risk, allows problems to recur, and generates a documented history of inadequate quality oversight. Tomorrow's Crop conducts and supports quality investigations that are thorough, scientifically sound, and defensible under FDA scrutiny.
What We Do
A detailed breakdown of our capabilities in this practice area.
Deviation Investigations
Structured investigation of manufacturing deviations, process excursions, and procedural failures. We apply systematic root cause methodology to identify what actually went wrong — not just what was observed — and link findings to appropriate corrective action.
Out-of-Specification (OOS) Investigations
Phase I and Phase II OOS investigations aligned with FDA guidance and 21 CFR Part 211.192. We conduct laboratory investigations, manufacturing investigations, and full OOS reports that meet regulatory expectations and support product disposition decisions.
Complaint Investigations
Consumer and customer complaint investigations that identify product quality issues, assess patient/consumer safety impact, and determine whether regulatory reporting obligations are triggered. We build complaint investigation systems and conduct individual investigations.
Adverse Event Investigations
Medical device adverse event investigations supporting MDR reporting, and dietary supplement serious adverse event investigations supporting SAE reporting. We assess reportability, conduct investigations, and prepare regulatory submissions.
Recall & Field Action Support
Investigation support for product recalls, market withdrawals, and field safety corrective actions — including root cause analysis, scope determination, effectiveness assessment, and regulatory communication support.
Investigation System Design
Design and implementation of investigation systems — procedures, forms, root cause tools, and documentation standards — that produce consistent, defensible investigation reports across your organization.
Investigation Training
Training for quality personnel, investigators, and laboratory staff in investigation methodology, root cause analysis, documentation standards, and regulatory requirements for specific investigation types.
Backlog Investigation Support
Support for organizations with investigation backlogs — prioritizing by risk, conducting or supporting individual investigations, and implementing systemic improvements to prevent future backlogs.
How We Work
Event Classification & Scoping
We classify the event by type and risk, determine the applicable regulatory requirements, and scope the investigation to ensure it addresses all relevant aspects without unnecessary scope creep.
Data Collection & Evidence Preservation
We collect and preserve all relevant evidence — batch records, laboratory data, equipment logs, environmental monitoring data, personnel records, and physical samples — before it is lost or altered.
Root Cause Analysis
We apply structured root cause analysis methodology to identify the true root cause — not just the immediate cause or contributing factors. We use fishbone analysis, 5-Why, fault tree analysis, or other appropriate methods based on the event type.
Investigation Report
We prepare a comprehensive investigation report that documents the event, evidence collected, root cause analysis, conclusions, and CAPA linkage — written to meet regulatory expectations and withstand inspection scrutiny.
CAPA & Regulatory Reporting
We link investigation findings to appropriate corrective and preventive actions, and assess whether regulatory reporting obligations are triggered — supporting MDR, SAE, or recall reporting as applicable.
Outcomes You Can Expect
Why Tomorrow's Crop
Quality investigations are only as good as the people conducting them. Our investigators have extensive experience conducting deviation, OOS, complaint, and adverse event investigations inside regulated companies — and have defended those investigations under FDA inspection. We know what investigators look for, what documentation is required, and how to write an investigation report that closes the issue rather than opening new ones.
Deepen Your Knowledge
Insights, ready-to-use documents, and training programs related to this practice area.
Insights
- Building a CAPA System That Satisfies Regulators
- Data Integrity Remediation: Where to Start
- Understanding FDA Inspection Priorities in 2026
Document Resources
- Deviation & Event Reporting SOPTC-CAPA-FUND-002
- Root Cause Analysis ToolkitTC-CAPA-FUND-003
- OOS / OOT Laboratory Investigation SystemTC-LAB-FUND-004
- CAPA Foundation SOP & FormsTC-CAPA-FUND-001
Ready to move forward?
Schedule a discovery call and let's define the right engagement for your organization.