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.
Regulatory Submission Blog
Application Areas
Clinical Stage
Product
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.
Instem Interact 2026 – A Resounding Success
Instem Team
Turning Insight into Innovation in Preclinical R&D
What the FDA Webcast Revealed About SEND (and Why It Matters)
Marc Ellison
“For the first time, the FDA openly acknowledged that they are rejecting some SEND datasets because the quality isn’t good enough. No ambiguity. Just a clear statement that quality matters, and that poor SEND has...
Stay up to Date
Get expert tips, industry news, and fresh content delivered to your inbox.
