Hygenix Blog

FDA’s Manufacturing PreCheck Pilot Program has moved from concept to an active intake and selection process.…

If you have received an Enhanced Turnover Package (ETOP) and felt immediate concern, you know the pattern: missing…

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

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

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

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

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