Stop Bleeding Money on Bad Investigations

QualiWrite™: The Only Deviation Management Software Built by FDA Remediation Experts

Every poorly written deviation investigation costs you $5,000–$20,000. Every missed root cause? $15,000–$50,000. A failed FDA inspection? $500,000–$2 million.
After 30+ years of pulling companies back from the brink of regulatory disaster, we built the software we wish had existed during every crisis we’ve solved.

The Crisis That’s Costing You Millions

The Political Pressure Trap

The Compliance Theater Problem

The Real Cost

Why We Built QualiWrite™?

After three decades of FDA remediation work, we were tired of arriving after the damage was done.

Every crisis taught us the same lesson: Bad investigations create bigger problems. So we built the software that prevents the crises we’ve spent decades solving.

Built with Compliance in Mind

Blocks Bad Investigations Before They Happen

Protects Quality from Political Pressure

Delivers Intelligence, Not Just Documentation

Built on 30 Years of Real-World Experience

Built on 30 Years of Real-World Experience

“This isn’t theoretical software—it’s a platform born from real inspections, real failures, and real recoveries.”

Proven Across All Life Sciences Sectors

Implementation That Overcomes Political Resistance

Phase 1: Discovery & Cultural Assessment

The Real Cost

What Our Clients Say About Us

“Altabrisa built a clear, achievable plan and worked with our team until every issue was resolved. We passed our first bi-annual inspection without a single citation.”

Head of Quality, Startup Biotech Company

“We were drowning in over 600 open deviations. Within months, they helped us streamline investigations, retrain our staff, and clear the backlog while improving quality. Incredible turnaround.”

QA Director, U.S. Contract Manufacturer

“We knew our QMS wouldn’t hold up under FDA scrutiny. Altabrisa assessed everything and guided us through a complete remediation We’re now fully aligned with FDA expectations.”

VP of Quality, Cell Therapy Startup

Why Quality-Focused Teams Choose Altabrisa?

Ready to Stop the Bleeding?

Every day you wait is another day of $5,000–$20,000 investigations that don’t solve problems.

Two Ways to Get Started Today

Option 1: Executive Strategy Session (60 mins)

Includes full deviation assessment, ROI projection, implementation roadmap.

Option 2: Technical Demo (45 mins)

Includes live demo, integration planning, training roadmap, validation walkthrough.