A powerful AI-driven SaaS platform built for FDA-regulated industries. Brought to you by Altabrisa Group’s 30+ years of real-world compliance expertise.
Designed for the unique needs of pharmaceutical, biotech, cell & gene therapy, and CDMO operations.
Suggests the best-fit root cause analysis tool based on your investigation details—5 Whys, Fishbone, or Fault Tree.
Ensures deviation classifications, CAPAs, and effectiveness checks follow FDA, EU GMP, and ICH Q9 expectations.
Step-by-step guidance with enforced completion before progression—standardized, consistent investigations.
Dynamically selects the appropriate tool and validates whether you’ve truly reached a root cause—not just a symptom.
Flags “human error” as a weak root cause and prompts deeper investigation into systemic breakdowns.
Auto-generates formatted investigation reports exportable to PDF or Word, complete with citations and classification summaries.
Built-in tracking of root causes, repeat issues, and CAPA failures across time or product lines.
QualiWrite™ incorporates Altabrisa’s AdaptiStrat™ methodology—strategic investigation design, not just checkboxes.
Reduce backlogs and time-to-closure with built-in logic to avoid dead-end investigations.
Final reports meet regulator expectations—so your investigations don’t get rejected.
“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.”
“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.”
“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.”
Book a discovery call or download the full capabilities overview to see how QualiWrite™ can improve the quality and consistency of your deviation investigations.
Altabrisa Group Limited, LLC
📞 Raleigh, NC: 919-297-2800
📞 Sheridan, WY: 307-461-5690
✉️ info@altabrisagroup.com
🌐 www.altabrisagroup.com
Are you looking to improve your quality standards and ensure compliance in pharmaceuticals, biotechnology, vaccines, and cell and gene therapy industries?
Contact us today and schedule a free initial consultation with the experts at Altabrisa Group.
We offer personalized advice and strategies to help you develop, implement, and optimize your cGMP quality systems, ensuring your products meet the highest standards of safety and effectiveness.
Reach out to us today and take the first step towards excellence in quality and compliance.
