What happens when SEND escapes Toxicology?
Marc Ellison
If we want AI to help us search, analyze and identify patterns in scientific data, giving it consistently structured data seems like a pretty good starting point.
Regulatory Submission Blog
Application Areas
Clinical Stage
Product
Webinar Recap: SEND v4.0 Readiness Starts at Data Collection
Instem Team
This webinar indicated
how SEND v4.0 readiness transcends simply translating existing data differently. In some cases, organizations will need to reconsider what information is captured and how it is captured.
What’s New in eQCM 10.0.1?
Instem Team
With the release of eQCM 10.0.1, Instem is introducing tighter document control and audit trail integrity for regulated environments.
Webinar Recap: When SEND Quality Matters Most
Instem Team
Our recent webinar, “When SEND Quality Matters Most”, explored the recent FDA communications regarding data quality, why regulatory expectations are shifting, where common issues arise, and how organizations can strengthen confidence before filing SEND datasets...
Webinar Recap: Closing Compliance Gaps with Compliance Builder
Instem Team
Comprehensive electronic recordkeeping is a cornerstone of all laboratory functions in regulated industries, but establishing and maintaining 21 CFR Part 11 compliance is challenging when processes are fragmented across multiple instruments and systems.
Why QC Laboratories Can’t Afford Blind Spots in Their File Systems
Instem Team
FDA Form 483 observations related to data integrity remain a persistent issue for the industry, and the consequences for a lab are significant.
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