Hygenix Blog

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…

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

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

Quality Management Maturity (QMM) is voluntary today, yet the direction is clear. The FDA’s Center for Drug…

If your User Requirement Specification (URS) isn’t ready, your project isn’t ready to go out for bid. Yet this is…