Zero Findings on Fifty Files
A Global Pharmaceutical Company
At a Glance
In pharmaceuticals, an investigation file is not just an internal record — it is a regulatory artifact. When the FDA requests files during an audit, every gap, every missing field, and every inconsistency is a potential finding. And findings have consequences: warning letters, consent decrees, and the kind of headlines that move stock prices.
The problem at this company was not a lack of investigators. It was a lack of structure. Each investigator had their own approach to documenting interviews, collecting evidence, and recording conclusions. Some wrote detailed narratives; others used shorthand that only they understood. Some attached supporting documents in an organized sequence; others uploaded files with no labeling or context.
The company implemented Ethico's MyCM platform with mandatory investigation templates — structured protocols that dictated exactly what information had to be captured at each stage of an investigation. The templates were not optional guidelines; they were system-enforced requirements. An investigator could not advance a case to the next stage without completing every required field.
Each template followed the company's investigation protocol: initial intake documentation, interview records with standardized question frameworks, evidence logs with mandatory labeling fields, findings summaries, and conclusion records with required rationale fields. The structure ensured that whether an investigation was conducted by a twenty-year veteran or a newly hired analyst, the output looked identical.
The next FDA audit told the story. The auditor requested ten files from a pool of fifty that had been managed through the new system. Every file followed the same structure. Every required field was populated. Every piece of evidence was labeled and linked to the appropriate investigation stage. The auditor found zero deficiencies.
The result was not a matter of luck or cherry-picking — the auditor selected the files, and the consistency held across the entire sample. The compliance team had moved from hoping that individual investigators would be thorough to knowing that the system required thoroughness as a precondition for case progression.
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