Resource Library
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The paperwork problem: How many FDA warning letters actually cite document failures
When people take a medication, they trust that it contains the right amount of active ingredient and is free of harmful contamination. Manufacturing and test records help verify that trust....
15 October 2026
4 min read
If Congress starts reviewing licensing deals, diligence gets a documentation problem
Historically, national security reviews were not a topic of conversation in biotech licensing deals. Things are changing.
5 October 2026
5 min read
When an AI Agent Runs the Analysis, Who Signs the Record?
When an AI agent runs the analysis, who signs the record?
Research and development organizations in 2026 find themselves in a unique position. AI agents are increasingly implemented into...
20 August 2026
6 min read