Hygenix Blog

Turnover Documentation Is Now Inspectable Under QMSR | Hygenix, Inc.
January 12, 2026
Turnover Documentation Is Now Inspectable Under QMSR

Under QMSR, cleanroom projects fail when leaders cannot demonstrate risk-based control of what was built, what…

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Key Actions for Achieving GMP Readiness in 2026 | Hygenix, Inc.
December 15, 2025
Key Actions for Achieving GMP Readiness in 2026

During the 2025 project cycle, delays and deviations in cleanroom and GMP facility builds were traced not to…

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The Hidden Weak Point in GMP Projects | Hygenix, Inc.
December 01, 2025
The Hidden Weak Point in GMP Projects

Many pharmaceutical and medical device leaders underestimate the extent to which documentation drives project…

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A Readiness Framework for PreCheck-Compliant Cleanroom Projects | Hygenix, Inc.
November 17, 2025
A Readiness Framework for PreCheck-Compliant Cleanroom Projects

The FDA’s PreCheck program has transitioned from concept to implementation, and it is already reshaping how new…

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You Scanned the Badge, Now What? | Hygenix, Inc.
November 03, 2025
You Scanned the Badge, Now What?

You worked at the booth. You had the right conversations. The scanner was busy, and the business cards were stacked…

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What GMP Buyers Will Screen for in 2026 | Hygenix, Inc.
October 20, 2025
What GMP Buyers Will Screen for in 2026

In pharma, buyers check everything. If your team can’t survive a 10-minute document pull and two Part 11 questions…

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FDA Precheck is Redefining Facility Readiness | Hygenix, Inc.
October 13, 2025
FDA Precheck Is Redefining Facility Readiness

In August 2025, the FDA launched the PreCheck program, reshaping how new pharmaceutical…

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